Class II
Ongoing
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]
- Company
- Amerisource Health Services Llc
- Recall Initiated
- October 9, 2025
- Posted
- October 22, 2025
- Recall Number
- D-0027-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 27,868 blister packs
- Firm Location
- Columbus, OH, United States
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
Nationwide within the United States
Lot / Code Info
Lot #: 1017392, Exp. Date 01/31/2026; 1017415, Exp. Date 12/31/2025.
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