Qualitest Pharmaceuticals

Complete recall history across all FDA and CPSC categories — 16 total recalls

Qualitest Pharmaceuticals 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 (16)

FDA drug safety enforcement actions by Qualitest Pharmaceuticals

Date Product Reason Class
Jul 20, 2015 ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for... Failed Tablet/Capsule Specifications; report of oversized and discolored tablets Class III
Jun 29, 2015 HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3... Failed Tablet/Capsule Specifications; The identification codes on some tablet... Class III
Jun 18, 2015 Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for... Failed Dissolution Specifications: During routine stability testing at the 1... Class III
Mar 25, 2015 PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10... Failed Impurities/Degradation Specifications: A stability lot was out of spec... Class III
Feb 23, 2015 PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan H... Presence of Foriegn Substance: Plastic cap closure particulates may be presen... Class II
Feb 13, 2015 AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32... Failed tablet specifications: One lot was found to contain oversized tablets. Class II
Dec 22, 2014 ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL,... Failed Impurities/Degradation Specifications: High out of specification resul... Class III
Sep 11, 2014 MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21)... Subpotent; 6 month stability time point Class III
Aug 27, 2014 OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Man... Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles. Class II
Aug 6, 2014 CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingre... Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three f... Class II
Aug 6, 2014 CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active i... Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three f... Class II
Aug 6, 2014 CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingred... Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three f... Class II
Dec 16, 2013 Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) ... Failed impurities/degradation specifications; out of specification for the kn... Class III
Aug 8, 2013 K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium... LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may... Class II
Aug 8, 2013 EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg),... LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may... Class II
Apr 19, 2013 GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufac... Failed Tablet/Capsule Specifications: One oversized tablet was found in a sea... 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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