FDA recall D-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

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.

Key facts

Status

Terminated

Initiation date

2020-01-06

Report date

2020-01-29

Termination date

2023-12-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grover Beach, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0793-2020