Class II
Ongoing
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.
This recall is currently active, issued August 6, 2025. It was issued by Nostrum Laboratories, Inc..
- Company
- Nostrum Laboratories, Inc.
- Recall Initiated
- July 11, 2025
- Posted
- August 6, 2025
- Recall Number
- D-0547-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 60,608 bottles
- Firm Location
- Bryan, OH, United States
- Official Source
- View on FDA website ↗
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
nationwide within the United States
Lot / Code Info
All Lots within expiry dates.
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