Home / Recalls / Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals / D-057-2013

D-057-2013 Class I Ongoing

Recalled by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals — Huntsville, AL

Recall Details

Product Type
Drugs
Report Date
November 28, 2012
Initiation Date
September 10, 2012
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,445 bottles

Product Description

HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21

Reason for Recall

Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.

Distribution Pattern

Nationwide.

Code Information

Lot number: C1440512A, Exp 12/13

Other recalls by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

  • D-0438-2017 Class III — DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QU (January 16, 2017)
  • D-1406-2015 Class II — Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-co (July 29, 2015)
  • D-138-2013 Class I — Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in (December 6, 2012)
  • D-010-2013 Class II — Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: (October 11, 2012)
  • D-1411-2012 Class III — HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. f (July 6, 2012)
  • D-1417-2012 Class III — HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle (July 6, 2012)