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Heritage Pharmaceuticals, Inc.

Complete recall history across all FDA and CPSC categories — 13 total recalls

Heritage Pharmaceuticals, Inc. 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 (13)

FDA drug safety enforcement actions by Heritage Pharmaceuticals, Inc.

Date Product Reason Class
May 21, 2019 PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx On... Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Inje... Class I
May 21, 2019 AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only,... Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Inje... Class I
May 3, 2019 Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manuf... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobu... Class II
May 3, 2019 Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Ma... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobu... Class II
May 3, 2019 Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufa... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobu... Class II
May 3, 2019 Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured b... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobu... Class II
May 3, 2019 Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured b... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobu... Class II
Feb 15, 2019 Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only,... Subpotent Drug. Class II
Jan 2, 2019 Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, ... Lack of Assurance of Sterility: complaints received about dried powder on the... Class II
Oct 15, 2018 Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only,... Lack of Assurance of Sterility: complaints received about dried powder on the... Class II
Mar 25, 2015 GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bot... Failed Impurities/Degradation Specifications: Out of specification for unknow... Class II
Feb 25, 2015 RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcu... Lack of Assurance of Sterility: Firm is recalling two injectable products due... Class II
Feb 25, 2015 Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by:... Lack of Assurance of Sterility: Firm is recalling two injectable products due... 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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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