Reported May 10, 2017 · Terminated
Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC…
Amneal Pharmaceuticals LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Amneal Pharmaceuticals LLC · 118 Beaver Trl · Glasgow, KY · 42141-1273
Is this the product you have?
- Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
- Lot codes and dates
Lot #: a) AR151324AR151322AR151325Exp. 9/2017AR160730AAR160731AAR160732AExp. 05/2018. b) AR151324AR151322AR151325Exp. 9/2017AR160730B5/2018
- Amount recalled
- 105,215 Bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specifications
This product could cause temporary or reversible health problems — stop using it.
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