FDAOctober 21, 2015drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

vintage pharmaceuticals llc dba qualitest pharmaceuticalsvintagevintage pharmaceuticals

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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