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.
Reported: August 6, 2025 Initiated: July 11, 2025 #D-0547-2025
Product Description
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.
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.
Details
- Recalling Firm
- Nostrum Laboratories, Inc.
- Units Affected
- 60,608 bottles
- Distribution
- nationwide within the United States
- Location
- Bryan, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Nostrum Laboratories, Inc.. Units affected: 60,608 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 6, 2025. Severity: Moderate. Recall number: D-0547-2025.
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