RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx onl...
FDA Recall #D-0162-2016 — Class III — October 21, 2015
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.
Recalling Firm
Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals — Huntsville, AL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
61,146 Bottles
Distribution
U.S. Nationwide
Code Information
Lot #: L088L13A, Expiry: 12/15; Lot #: L023F14A, Expiry: 5/16; Lot#: L024F14A, Expiry: 5/16.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated