H J Harkins Company Inc dba Pharma Pac recalls Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Compa
Recalled January 29, 2020 · FDA recall D-0793-2020 · H J Harkins Company Inc
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product. · FDA Class II
Units
7,212 tablets
Sold at
Distributed to Physicians in the following states: CA, FL, NC, and SC.
Description
CGMP Deviations: Presence of NDMA impurity detected in product.
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
Manufacturer(s)
H J Harkins Company Inc dba Pharma Pac
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →