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…

Recall date

October 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0162-2016

FDA classification

Class III

Brand / firm

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Sold / distributed

U.S. Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.