Recalls / Class III
Class IIID-0143-2017
Product
NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10
- Affected lot / code info
- Lot # 0598B151; Exp 03/18
Why it was recalled
Presence of Foreign Tablets/Capsules
Recalling firm
- Firm
- Actavis Elizabeth LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Elmora Ave, N/A, Elizabeth, New Jersey 07202-1106
Distribution
- Quantity
- 27,517 bottles
- Distribution pattern
- US
Timeline
- Recall initiated
- 2016-10-06
- FDA classified
- 2016-11-18
- Posted by FDA
- 2016-11-30
- Terminated
- 2017-05-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0143-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.