Recalls / Class III
Class IIID-0144-2017
Product
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
- Affected lot / code info
- Lot #155404 ; Exp 01/18 Lot #161139,163060,164054, 164809; Exp 03/18
Why it was recalled
Presence of Foreign Tablets/Capsules
Recalling firm
- Firm
- Amerisource Health Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 5283 cartons (100 capsules per carton = 528,300 capsules)
- Distribution pattern
- US
Timeline
- Recall initiated
- 2016-10-13
- FDA classified
- 2016-11-18
- Posted by FDA
- 2016-11-30
- Terminated
- 2017-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0144-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.