Bio-pharm, Inc. recalls Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pha
Recalled April 13, 2016 · FDA recall D-0809-2016 · Bio-pharm
Hazard
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing. · FDA Class III
Units
103,664 Bottles
Sold at
Nationwide and Puerto Rico
Description
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Product
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
Manufacturer(s)
Bio-pharm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →