Home / Recalls / Qualitest Pharmaceuticals / D-0411-2015

D-0411-2015 Class II Terminated

Recalled by Qualitest Pharmaceuticals — Huntsville, AL

Recall Details

Product Type
Drugs
Report Date
March 18, 2015
Initiation Date
February 23, 2015
Termination Date
July 12, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
972 bottles

Product Description

PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58.

Reason for Recall

Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.

Distribution Pattern

Nationwide

Code Information

Lot #: 0000001099; Exp. 03/16

Other recalls by Qualitest Pharmaceuticals

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  • 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-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-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)