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D-0397-2015 Class II Terminated

Recalled by Qualitest Pharmaceuticals — Huntsville, AL

FDA drug recall D-0397-2015 was initiated by Qualitest Pharmaceuticals on February 13, 2015 and is designated Class II. Reason for recall: Failed tablet specifications: One lot was found to contain oversized tablets. The recall status is terminated (terminated January 27, 2016). Affected quantity: 2808 bottles.

Recall Details

Product Type
Drugs
Report Date
March 11, 2015
Initiation Date
February 13, 2015
Termination Date
January 27, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2808 bottles

Product Description

AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot T018H14A, Exp 08/16

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)
  • 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-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