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H J Harkins Company Inc dba Pharma Pac

Complete recall history across all FDA and CPSC categories — 9 total recalls

H J Harkins Company Inc dba Pharma Pac appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (9)

FDA drug safety enforcement actions by H J Harkins Company Inc dba Pharma Pac

Date Product Reason Class
Apr 15, 2020 Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-coun... cGMP Deviations Class II
Mar 6, 2020 Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-... Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenata... Class II
Jan 6, 2020 Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count... CGMP Deviations: Presence of NDMA impurity detected in product. Class II
Jul 12, 2019 Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophth... CGMPs Deviations: Insufficient Quality Assurance controls over critical syste... Class II
Jun 24, 2019 Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torren... Microbial Contamination of Non-sterile Products: Potential product contaminat... Class II
Jun 24, 2019 Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by To... Microbial Contamination of Non-sterile Products: Potential product contaminat... Class II
Mar 4, 2019 Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 m... CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (N... Class II
Oct 18, 2018 GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg... Presence of Particulate Matter: Crystalline particles were noticed by manufac... Class II
Jul 26, 2018 Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkin... Carcinogen impurity detected in API used to manufacture drug product. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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