Drug Enforcement D-0547-2025

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.

Status

Ongoing

Classification

Class II

Report Date

August 6, 2025

Termination Date

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Product Information

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.
Product quantity
60,608 bottles
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.
Recall initiation reason
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Initial firm notification
Press Release
Distribution pattern
nationwide within the United States

Location & Firm

Recalling firm
Nostrum Laboratories, Inc.
Address
705 E Mulberry St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0547-2025
Event ID
97053
Recall initiation date
July 11, 2025
Center classification date
July 31, 2025
Code info
All Lots within expiry dates.
More code info
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