Home / Recalls / Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals / D-0326-2017

D-0326-2017 Class III Terminated

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

FDA drug recall D-0326-2017 was initiated by Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals on December 22, 2016 and is designated Class III. Reason for recall: Failed Stability Specifications The recall status is terminated (terminated September 18, 2017). Affected quantity: 1200 bottles.

Recall Details

Product Type
Drugs
Report Date
January 11, 2017
Initiation Date
December 22, 2016
Termination Date
September 18, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1200 bottles

Product Description

TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21

Reason for Recall

Failed Stability Specifications

Distribution Pattern

Nationwide

Code Information

T248H15A, Exp. 08/17

Other recalls by Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

  • D-0859-2017 Class III — HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured (May 8, 2017)
  • D-0162-2016 Class III — RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL ( (October 21, 2015)
  • D-0232-2016 Class II — HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufac (October 7, 2015)
  • D-1350-2015 Class III — AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: (August 13, 2015)

FDA data resources