H J Harkins Company Inc dba Pharma Pac recalls
FDA enforcement reports naming H J Harkins Company Inc dba Pharma Pac as the recalling firm.
- Recall reports
- 9
- Class I (serious)
- 0
- Most recent report
- Apr 22, 2020
- Apr 22, 2020Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (…Drug · H J Harkins Company Inc dba Pharma PaccGMP DeviationsClass II
- Mar 18, 2020Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42…Drug · H J Harkins Company Inc dba Pharma PacPresence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottleClass II
- Jan 29, 2020Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 countDrug · H J Harkins Company Inc dba Pharma PacCGMP Deviations: Presence of NDMA impurity detected in product.Class II
- Aug 7, 2019Neomycin 3Drug · H J Harkins Company Inc dba Pharma PacCGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.Class II
- Jul 3, 2019Diphenhydramine HCL Liquid, 12Drug · H J Harkins Company Inc dba Pharma PacMicrobial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).Class II
- Jul 3, 2019Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Phar…Drug · H J Harkins Company Inc dba Pharma PacMicrobial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).Class II
- Apr 17, 2019Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are whit…Drug · H J Harkins Company Inc dba Pharma PacCGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).Class II
- Feb 6, 2019GENTAMICIN OPTH-SOL 5ml Compare: GaramycinDrug · H J Harkins Company Inc dba Pharma PacPresence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.Class II
- Aug 8, 2018Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by HDrug · H J Harkins Company Inc dba Pharma PacCarcinogen impurity detected in API used to manufacture drug product.Class II