Class II · ModerateRecall completed
Rabeprazole Sodium Delayed Release Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: a) AR151324, AR151322, AR151325, Exp. 9/2017; AR160730A, AR160731A, AR160732A, Exp. 05/2018. b) AR151324, AR151322, AR151325, Exp. 9/2017; AR160730B, 5/2018.
Where it was soldNationwide within the US and PR
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Dissolution Specifications
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAmneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807 foreign manufacturer
| Distributed by / for | Amneal Pharmaceuticals, Bridgewater, NJ 08807 |
| NDC | 65162-0724-03 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Amneal Pharmaceuticals LLC |
| Distribution | Nationwide within the US and PR |
| Quantity | 105,215 Bottles |
| Recall initiated | 2016-12-12 |
| Report date | 2017-05-10 |
| Recall completed | 2019-04-11 |
| Recall number | D-0693-2017 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Glasgow KY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.