FDAFDA · Food and drugs·Recall number D-0162-2016
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.
Published November 11, 2015 · Recall initiated: October 21, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Distributor
- U.S. Nationwide
- Lot
- Lot #: L088L13A, Expiry: 12/15; Lot #: L023F14A, Expiry: 5/16; Lot#: L024F14A, Expiry: 5/16.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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