FDA-Drug2025-08-06Class II
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.
Nostrum Laboratories, Inc.
Hazard
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.
Sold states
nationwide within the United States
Affected count
60,608 bottles
Manufactured in
705 E Mulberry St, Bryan, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0547-2025Don't want to check this manually?
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