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H J Harkins Company Inc Recalls
9 recalls on record · August 8, 2018 to April 22, 2020 · Drugs
Recalls by year
18
19
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 22, 2020DrugsFDA
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
Hazard: cGMP Deviations
March 18, 2020DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42
Hazard: Presence 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 bottle
January 29, 2020DrugsFDA
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 Compa
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
August 7, 2019DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufa
Hazard: CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
July 3, 2019DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52
Hazard: Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
July 3, 2019DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, ND
Hazard: Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
April 17, 2019DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear
Hazard: CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
February 6, 2019DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Hazard: Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
August 8, 2018DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 4354
Hazard: Carcinogen impurity detected in API used to manufacture drug product.