Home / Recalls / Qualitest Pharmaceuticals / D-0037-2015

D-0037-2015 Class II Terminated

Recalled by Qualitest Pharmaceuticals — Huntsville, AL

Recall Details

Product Type
Drugs
Report Date
October 29, 2014
Initiation Date
August 6, 2014
Termination Date
February 2, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
181908 units

Product Description

CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC

Reason for Recall

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.

Distribution Pattern

Nationwide

Code Information

Codes: L049J12A, L067M12A, L079B13A, L079B13B, L077E13A, L010H13A, L011J13A, L101K13A

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-0331-2015 Class III — ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, pa (December 22, 2014)
  • 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-0039-2015 Class II — CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredien (August 6, 2014)