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
Reported: April 13, 2016 Initiated: December 17, 2015 #D-0809-2016
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.
Details
- Recalling Firm
- Bio-pharm, Inc.
- Units Affected
- 103,664 Bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Levittown, PA
Frequently Asked Questions
What product 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. Recalled by Bio-pharm, Inc.. Units affected: 103,664 Bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 13, 2016. Severity: Low. Recall number: D-0809-2016.
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