Qualitest Pharmaceuticals recalls
FDA enforcement reports naming Qualitest Pharmaceuticals as the recalling firm.
- Recall reports
- 16
- Class I (serious)
- 0
- Most recent report
- Sep 9, 2015
- Sep 9, 2015ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITE…Drug · Qualitest PharmaceuticalsFailed Tablet/Capsule Specifications; report of oversized and discolored tabletsClass III
- Jul 22, 2015HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 5…Drug · Qualitest PharmaceuticalsFailed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadableClass III
- Jul 8, 2015Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qu…Drug · Qualitest PharmaceuticalsFailed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.Class III
- Apr 15, 2015PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Prome…Drug · Qualitest PharmaceuticalsFailed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.Class III
- Mar 18, 2015PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromid…Drug · Qualitest PharmaceuticalsPresence of Foriegn Substance: Plastic cap closure particulates may be present in the product.Class II
- Mar 11, 2015AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only…Drug · Qualitest PharmaceuticalsFailed tablet specifications: One lot was found to contain oversized tablets.Class II
- Jan 14, 2015ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged…Drug · Qualitest PharmaceuticalsFailed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.Class III
- Oct 29, 2014CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in…Drug · Qualitest PharmaceuticalsSuperpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.Class II
- Oct 29, 2014CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in e…Drug · Qualitest PharmaceuticalsSuperpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.Class II
- Oct 29, 2014CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient…Drug · Qualitest PharmaceuticalsSuperpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.Class II
- MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 2…
- OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured…
- Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 1…
- EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM…
- K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbona…
- GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for:…
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