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 b
Recalled April 22, 2020 · FDA recall D-1246-2020 · H J Harkins Company Inc
Hazard
cGMP Deviations · FDA Class II
Units
9,000 tablets
Sold at
Product was distributed in CA and AZ.
Description
cGMP Deviations
Product
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
Manufacturer(s)
H J Harkins Company Inc dba Pharma Pac
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →