FDA-Drug2020-01-29Class II
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
H J Harkins Company Inc dba Pharma Pac
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product.
Sold states
Distributed to Physicians in the following states: CA, FL, NC, and SC.
Affected count
7,212 tablets
Manufactured in
1400 W Grand Ave Ste F, Grover Beach, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0793-2020Don't want to check this manually?
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