D-0027-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- October 22, 2025
- Initiation Date
- October 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,868 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 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.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 1017392, Exp. Date 01/31/2026; 1017415, Exp. Date 12/31/2025.