Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
Product description
Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Lot numbers, UPCs & expiration codes
Lot #: 131924, Exp 07/31/2015
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-1218-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 1, 2015
- FDA report date
- Jul 15, 2015
- Quantity
- 1,896 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1218-2015, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 71553
- Address
- 2550 John Glenn Ave
- Address (line 2)
- Suite A
- Code information
- Lot #: 131924, Exp 07/31/2015
- Postal code
- 43217-1188
- Report date
- Jul 15, 2015
- Product type
- Drugs
- Recall number
- D-1218-2015
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 1,896 cartons
- Termination date
- Feb 22, 2017
- Reason for recall
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 1, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2015