Why it was recalled
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Product description
AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10
Lot numbers, UPCs & expiration codes
Lot #: 6142626, Exp 09/19
Where it was sold
Nationwide in the USA.
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-1134-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 5, 2017
- FDA report date
- Sep 20, 2017
- Quantity
- 1212 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories LLC
Original FDA data
Every field from FDA enforcement report D-1134-2017, exactly as published.
Show all FDA fields
- City
- Montvale
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77948
- Address
- 180 Summit Ave Ste 200
- Code information
- Lot #: 6142626, Exp 09/19
- Postal code
- 07645-1722
- Report date
- Sep 20, 2017
- Product type
- Drugs
- Recall number
- D-1134-2017
- Classification
- Class III
- Recalling firm
- Ascend Laboratories LLC
- Product quantity
- 1212 bottles
- Termination date
- Apr 25, 2018
- Reason for recall
- PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- May 5, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 11, 2017