D-0143-2017 Class III Terminated

Recalled by Actavis Elizabeth LLC — Elizabeth, NJ

FDA drug recall D-0143-2017 was initiated by Actavis Elizabeth LLC on October 6, 2016 and is designated Class III. Reason for recall: Presence of Foreign Tablets/Capsules The recall status is terminated (terminated May 8, 2017). Affected quantity: 27,517 bottles.

Recall Details

Product Type
Drugs
Report Date
November 30, 2016
Initiation Date
October 6, 2016
Termination Date
May 8, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27,517 bottles

Product Description

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

Reason for Recall

Presence of Foreign Tablets/Capsules

Distribution Pattern

US

Code Information

Lot # 0598B151; Exp 03/18