FDA-Drug2025-09-03Class 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]
Hazard
CGMP Deviations: The recalling firm filed for Chapter 11 in September 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
Affected count
26,992 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-0598-2025More Amerisource Health Services LLC recalls
- FDA-Drug2026-05-27Amerisource Health Services Primidone Tablets recalled for trace Acemetacin contamination
- FDA-Drug2026-05-27Amerisource Primidone 250 mg tablets recalled for cross-contamination with Acemetacin
- FDA-Drug2026-04-01Meclizine Hydrochloride 12.5 mg tablets recalled for failed specifications
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