Recalls / Class II
Class IID-0793-2020
Product
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
- Affected lot / code info
- Lot #s: RAN63KG Exp. 05/20, RAN64KG Exp. 10/20, RAN65KG Exp. 11/20, RAN66KG Exp. 05/21
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm
- Firm
- H J Harkins Company Inc dba Pharma Pac
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1400 W Grand Ave Ste F, Grover Beach, California 93433-4221
Distribution
- Quantity
- 7,212 tablets
- Distribution pattern
- Distributed to Physicians in the following states: CA, FL, NC, and SC.
Timeline
- Recall initiated
- 2020-01-06
- FDA classified
- 2020-01-20
- Posted by FDA
- 2020-01-29
- Terminated
- 2023-12-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0793-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.