FDAFDA · Food and drugs·Recall number D-0809-2016
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
Published April 13, 2016 · Recall initiated: December 17, 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 Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bio-pharm, Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #s: 14G008, 14G013, 14G010, 14G015, 14G016, 14G021, 14G026, 14G028, Exp. 01/2016; 14K027, 14K023, Exp. 04/2016; 15B040, 15B041, Exp. 08/2016; 15E042, Exp. 11/2016; 15F019, 15F021, Exp. 12/2016; 15G038, Exp. 01/2017; 15H004, 15H008, Exp. 02/2017
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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