Home / Recalls / Qualitest Pharmaceuticals / D-0331-2015

D-0331-2015 Class III Terminated

Recalled by Qualitest Pharmaceuticals — Huntsville, AL

Recall Details

Product Type
Drugs
Report Date
January 14, 2015
Initiation Date
December 22, 2014
Termination Date
February 1, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 3936 bottles; b) 84420 bottles

Product Description

ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot #: a) L140H13B, Exp. 03/15; L001D14A. Exp. 08/15; b) L140H13A, Exp. 03/15; L205K13A, Exp. 05/15; L019L13A, L020L13A, Exp. 06/15; L001D14B, 08/15; L091D14A, Exp. 10/15

Other recalls by Qualitest Pharmaceuticals

  • D-1405-2015 Class III — ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: (July 20, 2015)
  • D-1239-2015 Class III — HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968 (June 29, 2015)
  • D1151-2015 Class III — Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for an (June 18, 2015)
  • D00432-2015 Class III — PROMETHAZINE VC WITH CODEINE SYRUP, EACH 5 ml contains: Codeine Phosphate 10 mg (March 25, 2015)
  • D-0411-2015 Class II — PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydr (February 23, 2015)
  • D-0397-2015 Class II — AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), (February 13, 2015)
  • D-1605-2014 Class III — MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) a (September 11, 2014)
  • D-1572-2014 Class II — OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufa (August 27, 2014)
  • D-0037-2015 Class II — CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingr (August 6, 2014)
  • D-0039-2015 Class II — CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredien (August 6, 2014)