FDA Drug · D-0793-2020

Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60

Class II · Terminated

CGMP Deviations: Presence of NDMA impurity detected in product.

Affected lots / codes — check yours against thisLot #s: RAN63KG Exp. 05/20, RAN64KG Exp. 10/20, RAN65KG Exp. 11/20, RAN66KG Exp. 05/21

Recalling firm: H J Harkins Company Inc dba Pharma Pac, Grover Beach, CA
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 7,212 tablets
Distribution: Distributed to Physicians in the following states: CA, FL, NC, and SC.
Recall initiated: January 6, 2020
Classified: January 20, 2020
Terminated: December 15, 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-0793-2020%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.

Check this brand across all 8 databases →