Why it was recalled
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Product description
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
Lot numbers, UPCs & expiration codes
Lot #: MP4344, Exp 04/2016
Where it was sold
Nationwide
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-0257-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 1, 2014
- FDA report date
- Dec 3, 2014
- Quantity
- 15,144 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0257-2015, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 69676
- Address
- 73 Route 31 N
- Code information
- Lot #: MP4344, Exp 04/2016
- Postal code
- 08534-3601
- Report date
- Dec 3, 2014
- Product type
- Drugs
- Recall number
- D-0257-2015
- Classification
- Class III
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 15,144 bottles
- Termination date
- Feb 26, 2016
- Reason for recall
- Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 1, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 21, 2014