Reported Apr 13, 2016 · Terminated
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage…
Bio-pharm, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bio-pharm, Inc. · 2091 Hartel Ave · Levittown, PA · 19057-4506
Is this the product you have?
- Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only
- Mfd ForHeritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
- Lot codes and dates
Lot #s: 14G00814G01314G01014G01514G01614G02114G02614G028Exp. 01/201614K02714K023Exp. 04/201615B04015B041Exp. 08/201615E042Exp. 11/201615F01915F021Exp. 12/201615G038Exp. 01/201715H00415H008Exp. 02/2017
- Amount recalled
- 103,664 Bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Bio-pharm, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.