FDA Drug · D-0645-2020

Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.

Class II · Terminated

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Affected lots / codes — check yours against thisP134458, Sept 2020 P134943, Aug 2020 P135840, Aug, 2020 P136622, April 2021 P136871, April 2021 P137347, April 2021 P137424, April 2021

Recalling firm: AAA Pharmaceutical, Inc., Lumberton, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 34,272 (24-count bottles)
Distribution: Product was distributed to one consignee who may have distributed the product further to their retail stores.
Recall initiated: December 26, 2019
Classified: January 6, 2020
Terminated: March 10, 2021
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0645-2020%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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