RecallDepth
Class II Terminated

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

Company
H J Harkins Company Inc Dba Pharma Pac
Recall Initiated
January 6, 2020
Posted
January 29, 2020
Recall Number
D-0793-2020
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
7,212 tablets
Firm Location
Grover Beach, CA, United States

Reason for Recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution

Distributed to Physicians in the following states: CA, FL, NC, and SC.

Lot / Code Info

Lot #s: RAN63KG Exp. 05/20, RAN64KG Exp. 10/20, RAN65KG Exp. 11/20, RAN66KG Exp. 05/21

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