Manufacturer

H J Harkins Company Inc dba Pharma Pac

9 recalls in our database name H J Harkins Company Inc dba Pharma Pac as the manufacturing or recalling firm.

What the numbers show

Total: 9
Critical: 0
Severe: 5
Most recent: 2020-04-22

Of the 9 recalls from H J Harkins Company Inc dba Pharma Pac we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (56%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

ModerateFDA (Drugs)·D-1246-2020·2020-04-22
FDA Recalls Acetaminophen and Codeine Tablets Due to Manufacturing Deviations
H J Harkins Company is recalling 9,000 tablets of Acetaminophen and Codeine Phosphate 300/30 mg due to cGMP deviations. The product was distributed in California and Arizona.
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 b
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1005-2020·2020-03-18
Acetaminophen Tablets Recalled Due to Foreign Tablet Contamination
H J Harkins Company Inc is recalling Acetaminophen 500 mg tablets because a foreign Women's Prenatal tablet was found in the product.
Product
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
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0793-2020·2020-01-29
Ranitidine Tablets Recalled Due to NDMA Impurity Detection
H.J. Harkins Company is recalling specific lots of Ranitidine 150 mg tablets because NDMA impurity was detected. The product was distributed to physicians in four states.
Product
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
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-1580-2019·2019-08-07
Pharma Pac Recalls Neomycin Ophthalmic Ointment for Quality Control Issues
Pharma Pac is recalling specific lots of Neomycin Ophthalmic Ointment due to insufficient quality assurance controls in the manufacturing facility.
Product
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
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1430-2019·2019-07-03
Diphenhydramine Liquid Recalled for Potential Microbial Contamination
H J Harkins Company is recalling Diphenhydramine HCL Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1429-2019·2019-07-03
Acetaminophen Children's Liquid Recalled for Microbial Contamination Risk
H J Harkins Company is recalling 40 bottles of Acetaminophen Children's Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1083-2019·2019-04-17
Losartan Potassium Tablets Recalled Due to Nitrosamine Impurity
Pharma Pac is recalling Losartan Potassium 100 mg tablets because traces of a nitrosamine impurity were found in the active ingredient.
Product
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.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0415-2019·2019-02-06
Gentamicin Ophthalmic Solution Recalled for Crystalline Particulate Matter
H J Harkins Company is recalling Gentamicin Ophthalmic Solution due to crystalline particles found during clarity testing.
Product
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1022-2018·2018-08-08
Valsartan tablets recalled due to carcinogen impurity in active ingredient
H.J. Harkins Co. is recalling Valsartan tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the product.
Product
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.
Category
Drug
Distribution
0 states