FDA-Drug2025-10-22Class II

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

Amerisource Health Services LLC
Hazard

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Sold states
Nationwide within the United States
Affected count
27,868 blister packs
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0027-2026

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