Skip to main content
Get Alerts

H J Harkins Company Inc dba Pharma Pac

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20181
20195
20203
Download CSV

FDA Recall Terminated Historical recordClass II

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

by H J Harkins Company Inc dba Pharma Pac

Reason
cGMP Deviations
Published
April 22, 2020
Distribution
Product was distributed in CA and AZ.

View recall →

FDA Recall Terminated Historical recordClass II

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. Harkins Co., Inc. Grover Beach, CA 93433

by H J Harkins Company Inc dba Pharma Pac

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
Published
March 18, 2020
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

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, 52959-0502-30 and 52959-0502-60

by H J Harkins Company Inc dba Pharma Pac

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Published
January 29, 2020
Distribution
Distributed to Physicians in the followi…

View recall →

FDA Recall Terminated Historical recordClass II

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 52959-0407-01

by H J Harkins Company Inc dba Pharma Pac

Reason
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Published
August 7, 2019
Distribution
Distributed in California

View recall →

FDA Recall Terminated Historical recordClass II

Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.

by H J Harkins Company Inc dba Pharma Pac

Reason
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04

by H J Harkins Company Inc dba Pharma Pac

Reason
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Published
July 3, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

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.

by H J Harkins Company Inc dba Pharma Pac

Reason
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Published
April 17, 2019
Distribution
Product was distributed to a physician's…

View recall →

FDA Recall Terminated Historical recordClass II

GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00

by H J Harkins Company Inc dba Pharma Pac

Reason
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Published
February 6, 2019
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

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 on one side and HH on the other side.

by H J Harkins Company Inc dba Pharma Pac

Reason
Carcinogen impurity detected in API used to manufacture drug product.
Published
August 8, 2018
Distribution
Product was distributed to a physician's…

View recall →

Showing 1–9 of 9 results

This page lists recalls that name H J Harkins Company Inc dba Pharma Pac as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.