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 Ph…
- Recall date
- December 17, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0809-2016
- FDA classification
- Class III
- Brand / firm
- Bio-pharm, Inc.
- Sold / distributed
- Nationwide and Puerto Rico
Why it was recalled
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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