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

Recall Number: D-1246-2020

Firm: H J Harkins Company Inc dba Pharma Pac

Classification: Class II

Status: Terminated

Report Date: 20200422

Initiation Date: 20200415

Termination Date: 20240214

cGMP Deviations

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