D-0598-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- September 3, 2025
- Initiation Date
- July 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,992 blister packs
Product Description
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]
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
Lot 1015038, Exp Date 07/31/2025, Lot 1015898, Exp Date 09/30/2025; Lot 1016873, Exp Date 10/31/2025 and Lot 1023398, Exp Date 07/31/2026.