Reported Nov 11, 2015 · Terminated

RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for:…

Vintage Pharmaceuticals LLC, dba Qualitest Pharmaceuticals

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals · 150 Vintage Dr NE · Huntsville, AL · 35811-8216

Is this the product you have?

  • RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only
  • Manufactured forQUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
  • NDC0603-9418-58
Lot codes and dates
  • Lot #: L088L13A
  • Expiry
    • 12/15
    • Lot #: L023F14A
  • Expiry
    • 5/16
    • Lot#: L024F14A
  • Expiry5/16
Amount recalled
61,146 Bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 23, 2016 · Data as of Sep 19, 6:33 PM UTC

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