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Qualitest Pharmaceuticals Recalls

16 recalls on record · May 1, 2013 to September 9, 2015 · Drugs

Recalls by year

Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

September 9, 2015DrugsFDA

Qualitest Pharmaceuticals recalls ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, A

Hazard: Failed Tablet/Capsule Specifications; report of oversized and discolored tablets

July 22, 2015DrugsFDA

Qualitest Pharmaceuticals recalls HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1

Hazard: Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable

July 8, 2015DrugsFDA

Qualitest Pharmaceuticals recalls Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vinta

Hazard: Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.

April 15, 2015DrugsFDA

Qualitest Pharmaceuticals recalls PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine Hydrochloride 6.25 mg, Ph

Hazard: Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.

March 18, 2015DrugsFDA

Qualitest Pharmaceuticals recalls PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONF

Hazard: Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.

March 11, 2015DrugsFDA

Qualitest Pharmaceuticals recalls AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PH

Hazard: Failed tablet specifications: One lot was found to contain oversized tablets.

January 14, 2015DrugsFDA

Qualitest Pharmaceuticals recalls ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC

Hazard: Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.

October 29, 2014DrugsFDA

Qualitest Pharmaceuticals recalls CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen U

Hazard: Superpotent 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.

October 29, 2014DrugsFDA

Qualitest Pharmaceuticals recalls CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen

October 29, 2014DrugsFDA

Qualitest Pharmaceuticals recalls CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminop

October 1, 2014DrugsFDA

Qualitest Pharmaceuticals recalls MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-45

Hazard: Subpotent; 6 month stability time point

September 10, 2014DrugsFDA

Qualitest Pharmaceuticals recalls OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, H

Hazard: Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.

January 8, 2014DrugsFDA

Qualitest Pharmaceuticals recalls Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only

Hazard: Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.

September 18, 2013DrugsFDA

Qualitest Pharmaceuticals recalls EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM BICARBONATE AND POTASSIUM CHLORI

Hazard: LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.

September 18, 2013DrugsFDA

Qualitest Pharmaceuticals recalls K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Effervescent Tablets For Oral

Hazard: LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.

May 1, 2013DrugsFDA

Qualitest Pharmaceuticals recalls GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Hunts

Hazard: Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.