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.

Recall Number: D-0162-2016

Firm: Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Classification: Class III

Status: Terminated

Report Date: 20151111

Initiation Date: 20151021

Termination Date: 20161023

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

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.