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FDAFDA · Food and drugs·Recall number 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

Published January 29, 2020 · Recall initiated: January 6, 2020

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

CGMP Deviations: Presence of NDMA impurity detected in product.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
H J Harkins Company Inc dba Pharma Pac
Distributor
Distributed to Physicians in the following states: CA, FL, NC, and SC.
Lot
Lot #s: RAN63KG Exp. 05/20, RAN64KG Exp. 10/20, RAN65KG Exp. 11/20, RAN66KG Exp. 05/21
Risk classification
Class II
Area (FDA)
drug
Country
United States

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