# MR PHARMA · 99-39 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For MR PHARMA · 99-39 · INDIA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is INDIA; product is Lakshadi Guggul Tablets | Lakshadi Guggul Tablets; product code is 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C; date published is 02/20/2024; address is 1 New Rose Colony , Rajpura Road; Gali N0 , Hira Garh, Punjab INDIA, verified against its source on 2026-09-16.

- **Firm:** MR PHARMA _(verified: appears in the quote below)_
- **Import alert:** 99-39
- **Import alert name:** Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- **Country:** INDIA _(verified: appears in the quote below)_
- **Address:** 1 New Rose Colony , Rajpura Road; Gali N0 , Hira Garh, Punjab INDIA _(verified: appears in the quote below)_
- **Date published:** 02/20/2024 _(verified: appears in the quote below)_
- **Product code:** 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. _(verified: each item appears in the quote below)_
- **Product:** Lakshadi Guggul Tablets | Lakshadi Guggul Tablets _(verified: each item appears in the quote below)_
- **FDA notes:** The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the product appears to be misbranded within the meaning of: Section 403 (q) of the Act in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Specifically, in that the serving size declared on the outside container and product container is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Additionally, a Supplement Facts label is not present in accordance with 21 CFR 101.36 and 21 CFR 101.9. Ingredients must be declared appropriately within the Supplement Facts label in accordance with 21 CFR 101.36 and 21 CFR 101.9 Section 403(i)(2) of the Act, in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act, in that the product label fails to specify the part of the plant for each declared botanical is derived from in accordance with 21 CFR 101.4(h)(1), e.g., guggul and aloe vera. | The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the product appears to be misbranded within the meaning of: Section 403 (q) of the Act in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Specifically, in that the serving size declared on the outside container and product container is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Additionally, a Supplement Facts label is not present in accordance with 21 CFR 101.36 and 21 CFR 101.9. Ingredients must be declared appropriately within the Supplement Facts label in accordance with 21 CFR 101.36 and 21 CFR 101.9 Section 403(i)(2) of the Act, in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act, in that the product label fails to specify the part of the plant for each declared botanical is derived from in accordance with 21 CFR 101.4(h)(1), e.g., guggul and aloe vera. _(verified: each item appears in the quote below)_

## What the source says

> MR PHARMA Date Published : 02/20/2024 1 New Rose Colony , Rajpura Road; Gali N0 , Hira Garh, Punjab INDIA 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 02/20/2024 Desc: Lakshadi Guggul Tablets Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the product appears to be misbranded within the meaning of: Section 403 (q) of the Act in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Specifically, in that the serving size declared on the outside container and product container is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Additionally, a Supplement Facts label is not present in accordance with 21 CFR 101.36 and 21 CFR 101.9. Ingredients must be declared appropriately within the Supplement Facts label in accordance with 21 CFR 101.36 and 21 CFR 101.9 Section 403(i)(2) of the Act, in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act, in that the product label fails to specify the part of the plant for each declared botanical is derived from in accordance with 21 CFR 101.4(h)(1), e.g., guggul and aloe vera. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 02/20/2024 Desc: Lakshadi Guggul Tablets Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the product appears to be misbranded within the meaning of: Section 403 (q) of the Act in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Specifically, in that the serving size declared on the outside container and product container is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Additionally, a Supplement Facts label is not present in accordance with 21 CFR 101.36 and 21 CFR 101.9. Ingredients must be declared appropriately within the Supplement Facts label in accordance with 21 CFR 101.36 and 21 CFR 101.9 Section 403(i)(2) of the Act, in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act, in that the product label fails to specify the part of the plant for each declared botanical is derived from in accordance with 21 CFR 101.4(h)(1), e.g., guggul and aloe vera.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_1144.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/).