D-0793-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 29, 2020
- Initiation Date
- January 6, 2020
- Termination Date
- December 15, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,212 tablets
Product Description
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
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution Pattern
Distributed to Physicians in the following states: CA, FL, NC, and SC.
Code Information
Lot #s: RAN63KG Exp. 05/20, RAN64KG Exp. 10/20, RAN65KG Exp. 11/20, RAN66KG Exp. 05/21