Why it was recalled
Presence of Foreign Tablets/Capsules
Product description
AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217
Lot numbers, UPCs & expiration codes
Lot #155404 ; Exp 01/18 Lot #161139,163060,164054, 164809; Exp 03/18
Where it was sold
US
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-0144-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 13, 2016
- FDA report date
- Nov 30, 2016
- Quantity
- 5283 cartons (100 capsules per carton = 528,300 capsules)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services
Original FDA data
Every field from FDA enforcement report D-0144-2017, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 75470
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #155404 ; Exp 01/18 Lot #161139,163060,164054, 164809; Exp 03/18
- Postal code
- 43217-1188
- Report date
- Nov 30, 2016
- Product type
- Drugs
- Recall number
- D-0144-2017
- Classification
- Class III
- Recalling firm
- Amerisource Health Services
- Product quantity
- 5283 cartons (100 capsules per carton = 528,300 capsules)
- Termination date
- Sep 28, 2017
- Reason for recall
- Presence of Foreign Tablets/Capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217
- Distribution pattern
- US
- Recall initiation date
- Oct 13, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 18, 2016