Why it was recalled
Failed Dissolution Specifications
Product description
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 numbers, UPCs & expiration codes
Lot #: 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 sold
Nationwide within the US and PR
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0693-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 12, 2016
- FDA report date
- May 10, 2017
- Quantity
- 105,215 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-0693-2017, exactly as published.
Show all FDA fields
- City
- Glasgow
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 76627
- Address
- 118 Beaver Trl
- Code information
- Lot #: a) AR151324, AR151322, AR151325, Exp. 9/2017; AR160730A, AR160731A, AR160732A, Exp. 05/2018. b) AR151324, AR151322, AR151325, Exp. 9/2017; AR160730B, 5/2018.
- Postal code
- 42141-1273
- Report date
- May 10, 2017
- Product type
- Drugs
- Recall number
- D-0693-2017
- Classification
- Class II
- Recalling firm
- Amneal Pharmaceuticals LLC
- Product quantity
- 105,215 Bottles
- Termination date
- Apr 11, 2019
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the US and PR
- Recall initiation date
- Dec 12, 2016
- Initial firm notification
- Letter
- Center classification date
- May 2, 2017