Acetaminophen and Codeine Phosphate 300/30 mg tablet recalled over manufacturing violations

Recall date

April 15, 2020

Source

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

Official notice title

H J Harkins Company Inc dba Pharma Pac recalls Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count…

Recall number

D-1246-2020

FDA classification

Class II

Brand / firm

H J Harkins Company Inc dba Pharma Pac

Sold / distributed

Product was distributed in CA and AZ.

Why it was recalled

cGMP Deviations

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

What was recalled

Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433