FDA recall D-0547-2025

Nostrum Laboratories, Inc. · Class II · 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.

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

Key facts

Status
Ongoing
Initiation date
2025-07-11
Report date
2025-08-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bryan, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0547-2025