Drug product
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
D-0547-2025
Product summary
- Event
- Event 97053
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 60,608 bottles
- Official record key
drug-enforcement:D-0547-2025
Official wording
Reason: 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.
Code information: All Lots within expiry dates.
Distribution pattern: nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations