FDA-Drug2022-02-16Class II

Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00

ULTRAtab Laboratories, Inc.
Hazard

CGMP Deviations

Sold states
Bulk product was distributed to 3 distributors who may have distributed finished product.
Affected count
1,527,203 tablets
Manufactured in
50 Toc Dr, N/A, Highland, NY, United States
Products
Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0542-2022

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