# TIL HEALTHCARE PVT LTD · 66-41 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For TIL HEALTHCARE PVT LTD · 66-41 · INDIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is INDIA; product is Apetamin Tablets | Apetamin Tablets | Apetamin Tablets | Astymin Amino Acids & Multivitamins Syrup | Apetamin Capsules | Apetamin Syrup | Apetamin Tablets | Astymin Amino Acids & Multivitamins Syrup | Apetamin Syrup | Apetamin Capsules | Apetamin Tablets | Astymin Amino Acids & Multivitamins Syrup | Apetamin Capsules | Apetamin Syrup | Apetamin Capsules | Apetamin Tablets | Apetamin Syrup | Astymin Amino Acids & Multivitamins Syrup | Apetamin Tablets | Apetamin Tablets | Apetamin Capsules | Apetamin Syrup | Astymin Amino Acids & Multivitamins Syrup; product code is 54 A - - 02 Vitamin B1 (Thiamine) | 54 A - - 04 Vitamin B6 (Pyridoxine) | 54 A - - 07 Nicotinamide (Niacinamide) (Vitamin) | 54 A - - -- Vitamin | 54 A - - -- Vitamin | 54 A - - -- Vitamin | 54 C - - 13 L-Lysine (Protein) | 54 C - - -- Protein | 54 F - - -- Herbal & Botanicals(other than teas) | 54 F - - -- Herbal & Botanicals(other than teas) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) | 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) | 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) | 61 - - - -- Human and Animal Drugs | 63 N - - 04 Dexpanthenol (Cholinergic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - -- Patent Medicines, Etc; date published is 02/24/2017; address is 100, Sri City Sez , Irugulam Post, Andhra Pradesh INDIA, verified against its source on 2026-09-16.

- **Firm:** TIL HEALTHCARE PVT LTD _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** INDIA _(verified: appears in the quote below)_
- **Address:** 100, Sri City Sez , Irugulam Post, Andhra Pradesh INDIA _(verified: appears in the quote below)_
- **Date published:** 02/24/2017 _(verified: appears in the quote below)_
- **Product code:** 54 A - - 02 Vitamin B1 (Thiamine) | 54 A - - 04 Vitamin B6 (Pyridoxine) | 54 A - - 07 Nicotinamide (Niacinamide) (Vitamin) | 54 A - - -- Vitamin | 54 A - - -- Vitamin | 54 A - - -- Vitamin | 54 C - - 13 L-Lysine (Protein) | 54 C - - -- Protein | 54 F - - -- Herbal & Botanicals(other than teas) | 54 F - - -- Herbal & Botanicals(other than teas) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) | 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) | 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) | 61 - - - -- Human and Animal Drugs | 63 N - - 04 Dexpanthenol (Cholinergic) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - -- Patent Medicines, Etc _(verified: each item appears in the quote below)_
- **Product:** Apetamin Tablets | Apetamin Tablets | Apetamin Tablets | Astymin Amino Acids & Multivitamins Syrup | Apetamin Capsules | Apetamin Syrup | Apetamin Tablets | Astymin Amino Acids & Multivitamins Syrup | Apetamin Syrup | Apetamin Capsules | Apetamin Tablets | Astymin Amino Acids & Multivitamins Syrup | Apetamin Capsules | Apetamin Syrup | Apetamin Capsules | Apetamin Tablets | Apetamin Syrup | Astymin Amino Acids & Multivitamins Syrup | Apetamin Tablets | Apetamin Tablets | Apetamin Capsules | Apetamin Syrup | Astymin Amino Acids & Multivitamins Syrup _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. | The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. | The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. | Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. | The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’. | The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'. | The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. | Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. | The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'. | The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’. | The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. | Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. | The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’. | The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'. | The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’. | The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. | The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'. | Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. | The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. | The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. | The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’. | The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'. | Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. _(verified: each item appears in the quote below)_

## What the source says

> TIL HEALTHCARE PVT LTD Date Published : 02/24/2017 100, Sri City Sez , Irugulam Post, Andhra Pradesh INDIA 54 A - - 02 Vitamin B1 (Thiamine) Date Published: 12/13/2021 Desc: Apetamin Tablets Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. 54 A - - 04 Vitamin B6 (Pyridoxine) Date Published: 12/13/2021 Desc: Apetamin Tablets Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. 54 A - - 07 Nicotinamide (Niacinamide) (Vitamin) Date Published: 12/13/2021 Desc: Apetamin Tablets Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. 54 A - - -- Vitamin Date Published: 03/06/2024 Desc: Astymin Amino Acids & Multivitamins Syrup Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 54 A - - -- Vitamin Date Published: 11/23/2021 Desc: Apetamin Capsules Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’. 54 A - - -- Vitamin Date Published: 02/24/2017 Desc: Apetamin Syrup Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'. 54 C - - 13 L-Lysine (Protein) Date Published: 12/13/2021 Desc: Apetamin Tablets Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. 54 C - - -- Protein Date Published: 03/06/2024 Desc: Astymin Amino Acids & Multivitamins Syrup Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 54 F - - -- Herbal & Botanicals(other than teas) Date Published: 02/24/2017 Desc: Apetamin Syrup Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'. 54 F - - -- Herbal & Botanicals(other than teas) Date Published: 11/23/2021 Desc: Apetamin Capsules Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 12/13/2021 Desc: Apetamin Tablets Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. Date Published: 03/06/2024 Desc: Astymin Amino Acids & Multivitamins Syrup Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. Date Published: 11/23/2021 Desc: Apetamin Capsules Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’. 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. Date Published: 02/24/2017 Desc: Apetamin Syrup Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'. 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) Date Published: 11/23/2021 Desc: Apetamin Capsules Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’. 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) Date Published: 12/13/2021 Desc: Apetamin Tablets Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. 61 X - - 14 Cyproheptadine HCl (Anti-Histaminic) Date Published: 02/24/2017 Desc: Apetamin Syrup Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'. 61 - - - -- Human and Animal Drugs Date Published: 03/06/2024 Desc: Astymin Amino Acids & Multivitamins Syrup Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 63 N - - 04 Dexpanthenol (Cholinergic) Date Published: 12/13/2021 Desc: Apetamin Tablets Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 12/13/2021 Desc: Apetamin Tablets Notes: The product appears to be an unapproved new drug, as the following statements on the product package insert and packaging documents the intended use of this product: “Loss of appetite and poor eating habits”, “Anorexia after a brief illness” and “Patients experiencing loss of appetite during convalescence following surgery or after any major illness”. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 11/23/2021 Desc: Apetamin Capsules Notes: The product appears to be an unapproved new drug as the product’s labeling includes statements such as (not an all-inclusive list): ‘…in the treatment of acute and chronic allergies and pruritis, such as dermatitis, including neurodermatitis, and neurodermatosis circumscripta, eczema, eczematoid dermatitis, dermatographism, mild, local allergic reactions to insect bites, hay fever, and other seasonal rhinitis, perennial allergic and vasomotor rhinitis, allergic conjunctivitis…’. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 02/24/2017 Desc: Apetamin Syrup Notes: The product appears to be an unapproved new drug as the product package insert and packaging documents include claims such as: 'Indications: Loss of appetite and poor eating habits; Anorexia after a brief illness; Patients experiencing loss of appetite during convalescence following surgery or after any major illness'. 66 V - - -- Patent Medicines, Etc Date Published: 03/06/2024 Desc: Astymin Amino Acids & Multivitamins Syrup Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).