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D1151-2015 Class III Terminated

Recalled by Qualitest Pharmaceuticals — Huntsville, AL

FDA drug recall D1151-2015 was initiated by Qualitest Pharmaceuticals on June 18, 2015 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated October 23, 2016). Affected quantity: 2016 bottles.

Recall Details

Product Type
Drugs
Report Date
July 8, 2015
Initiation Date
June 18, 2015
Termination Date
October 23, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2016 bottles

Product Description

Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21.

Reason for Recall

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.

Distribution Pattern

Nationwide

Code Information

Lot #: T142A14A, T143A14A, T144A14A, Exp 01/16

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)
  • 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-0038-2015 Class II — CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredie (August 6, 2014)
  • D-0037-2015 Class II — CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingr (August 6, 2014)

FDA data resources