Ranitidine recalled over manufacturing violations

Recall date

January 6, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 Comp…

Recall number

D-0793-2020

FDA classification

Class II

Brand / firm

H J Harkins Company Inc dba Pharma Pac

Sold / distributed

Distributed to Physicians in the following states: CA, FL, NC, and SC.

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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