Home / Recalls / Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals / D-1411-2012

D-1411-2012 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
July 18, 2012
Initiation Date
July 6, 2012
Termination Date
February 1, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
54,431 bottles

Product Description

HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.

Reason for Recall

Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.

Distribution Pattern

Nationwide and Puerto Rico.

Code Information

Lot #: L072B11A, Exp 8/12; L102C11A, L103C11A, Exp 10/12; L046D11A, L082F11A, L089F11A, Exp 11/12; L148J11A, L149J11A, L150J11A, Exp 03/13; and L151J11A, Exp 04/13

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-057-2013 Class I — HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count b (September 10, 2012)
  • D-1417-2012 Class III — HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle (July 6, 2012)