D-0809-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 13, 2016
- Initiation Date
- December 17, 2015
- Termination Date
- May 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 103,664 Bottles
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
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