FDA Drug · D-0825-2020

Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram

Class II · Terminated

CGMP Deviations: Presence of NDMA impurity detected in product.

Affected lots / codes — check yours against thisLot #:11E0585, Exp. October 2023

Recalling firm: Spectrum Laboratory Products, Gardena, CA
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: N/A
Distribution: The recalled API was distributed to pharmacies in the following states: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY. The API was also distributed internationally to Canada and UAE.
Recall initiated: January 14, 2020
Classified: February 4, 2020
Terminated: December 5, 2023
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-0825-2020%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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