Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals recalls RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: Q
Recalled November 11, 2015 · FDA recall D-0162-2016 · Vintage Pharmaceuticals LLC,
Hazard
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben. · FDA Class III
Units
61,146 Bottles
Sold at
U.S. Nationwide
Description
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Product
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.
Manufacturer(s)
Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →