FDA recall D-0809-2016

Bio-pharm, Inc. · Class III · drug

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

Reason for recall

Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2015-12-17
Report date: 2016-04-13
Termination date: 2017-05-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Levittown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0809-2016