Amherst Laboratories · 99-39 · PHILIPPINES
For Amherst Laboratories · 99-39 · PHILIPPINES, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is PHILIPPINES; product is Tiki-Tiki Star Syrup Lysine and B Complex Vitamins A C D and E | Tiki-Tiki Star Syrup Lysine and B Complex Vitamins A C D and E; product code is 36 B - - 99 Syrups and Molasses, N.E.C. | 54 A - - 99 Vitamin, N.E.C; date published is 05/11/2023; address is Greenfield Industrial , Laguna, Calabarzon PHILIPPINES, verified against its source on 2026-09-16.
- Firm
- Amherst Laboratories verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- PHILIPPINES verified
- Address
- Greenfield Industrial , Laguna, Calabarzon PHILIPPINES verified
- Date published
- 05/11/2023 verified
- Product code
- 36 B - - 99 Syrups and Molasses, N.E.C. | 54 A - - 99 Vitamin, N.E.C. each item verified
- Product
- Tiki-Tiki Star Syrup Lysine and B Complex Vitamins A C D and E | Tiki-Tiki Star Syrup Lysine and B Complex Vitamins A C D and E each item verified
- FDA notes
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within of section: 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to declare the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and section 1453(a)(3)(A)(i) of the FPLA [15 U.S.C. §1453(a)(3)(A)(i)] because the labels fail to declare a complete and accurate statement of the net quantity of contents on the principal display panel as required by 21 CFR 101.7. 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the labels fail to declare the common or usual names of each dietary ingredient and dietary ingredient source as required by 21 CFR 101.36 and 21 CFR 101.4. 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within of section: 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to declare the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and section 1453(a)(3)(A)(i) of the FPLA [15 U.S.C. §1453(a)(3)(A)(i)] because the labels fail to declare a complete and accurate statement of the net quantity of contents on the principal display panel as required by 21 CFR 101.7. 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the labels fail to declare the common or usual names of each dietary ingredient and dietary ingredient source as required by 21 CFR 101.36 and 21 CFR 101.4. 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend. each item verified
What the source says
Amherst Laboratories Date Published : 05/11/2023 Greenfield Industrial , Laguna, Calabarzon PHILIPPINES 36 B - - 99 Syrups and Molasses, N.E.C. Date Published: 05/11/2023 Desc: Tiki-Tiki Star Syrup Lysine and B Complex Vitamins A C D and E Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within of section: 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to declare the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and section 1453(a)(3)(A)(i) of the FPLA [15 U.S.C. §1453(a)(3)(A)(i)] because the labels fail to declare a complete and accurate statement of the net quantity of contents on the principal display panel as required by 21 CFR 101.7. 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the labels fail to declare the common or usual names of each dietary ingredient and dietary ingredient source as required by 21 CFR 101.36 and 21 CFR 101.4. 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend. 54 A - - 99 Vitamin, N.E.C. Date Published: 05/11/2023 Desc: Tiki-Tiki Star Syrup Lysine and B Complex Vitamins A C D and E Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within of section: 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to declare the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] and section 1453(a)(3)(A)(i) of the FPLA [15 U.S.C. §1453(a)(3)(A)(i)] because the labels fail to declare a complete and accurate statement of the net quantity of contents on the principal display panel as required by 21 CFR 101.7. 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the labels fail to declare the common or usual names of each dietary ingredient and dietary ingredient source as required by 21 CFR 101.36 and 21 CFR 101.4. 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or, with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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