Qualitest Pharmaceuticals

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1405-2015Class IIIALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTJuly 20, 2015
D-1239-2015Class IIIHydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDCJune 29, 2015
D1151-2015Class IIIDisulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest PharmJune 18, 2015
D00432-2015Class IIIPROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg, Promethazine HydroMarch 25, 2015
D-0411-2015Class IIPROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACHFebruary 23, 2015
D-0397-2015Class IIAMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, ManufactureFebruary 13, 2015
D-0331-2015Class IIIACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (December 22, 2014
D-1605-2014Class IIIMethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blistSeptember 11, 2014
D-1572-2014Class IIOXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITESAugust 27, 2014
D-0039-2015Class IICHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 August 6, 2014
D-0037-2015Class IICHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mLAugust 6, 2014
D-0038-2015Class IICHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in each 5 mL = 1August 6, 2014
D-394-2014Class IIICetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480December 16, 2013
D-1037-2013Class IIEFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM BICARBONATE August 8, 2013
D-1036-2013Class IIK EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate EffervesceAugust 8, 2013
D-298-2013Class IIGLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest PhApril 19, 2013