Drug product
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]
D-0027-2026
Product summary
- Event
- Event 97794
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 27,868 blister packs
- Official record key
drug-enforcement:D-0027-2026
Official wording
Reason: 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.
Code information: Lot #: 1017392, Exp. Date 01/31/2026; 1017415, Exp. Date 12/31/2025.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations