Home / Recalls / Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals / D-0162-2016

D-0162-2016 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
November 11, 2015
Initiation Date
October 21, 2015
Termination Date
October 23, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
61,146 Bottles

Product Description

RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.

Reason for Recall

Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.

Distribution Pattern

U.S. Nationwide

Code Information

Lot #: L088L13A, Expiry: 12/15; Lot #: L023F14A, Expiry: 5/16; Lot#: L024F14A, Expiry: 5/16.

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-0326-2017 Class III — TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QU (December 22, 2016)
  • 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)