Grover Beach, CA, United States
H J Harkins Company Inc dba Pharma Pac recalls
8 recalls recorded since 2018, most recently on 15 April 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)0
Terminated or completed8
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 15 April 2020
- Terminated
- 14 February 2024
- Reason
- cGMP Deviations
- Distribution
- Product was distributed in CA and AZ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1246-2020
- 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 52959-000
Terminated Class II Drugs
- Recall started
- 6 March 2020
- Terminated
- 17 January 2024
- Reason
- 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
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1005-2020
- Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J.
Terminated Class II Drugs
- Recall started
- 6 January 2020
- Terminated
- 15 December 2023
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Distribution
- Distributed to Physicians in the following states: CA, FL, NC, and SC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0793-2020
- Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20,
Terminated Class II Drugs
- Recall started
- 12 July 2019
- Terminated
- 5 June 2023
- Reason
- CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
- Distribution
- Distributed in California
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1580-2019
- Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-040
Terminated Class II Drugs
- Recall started
- 24 June 2019
- Terminated
- 24 May 2023
- Reason
- Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Distribution
- Nationwide Within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1429-2019, D-1430-2019
- Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04
- Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
Terminated Class II Drugs
- Recall started
- 4 March 2019
- Terminated
- 24 May 2023
- Reason
- CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
- Distribution
- Product was distributed to a physician's office in California.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1083-2019
- Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.
Terminated Class II Drugs
- Recall started
- 18 October 2018
- Terminated
- 6 May 2021
- Reason
- Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0415-2019
- GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Terminated Class II Drugs
- Recall started
- 26 July 2018
- Terminated
- 18 January 2019
- Reason
- Carcinogen impurity detected in API used to manufacture drug product.
- Distribution
- Product was distributed to a physician's office.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1022-2018
- Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.