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Recall Observatory FDA recall evidence

Drug 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

D-0143-2017

October 06, 2016

Class III

Product summary

Firm
Actavis Elizabeth LLC
Event
Event 75445
Status
Terminated
Classification
Class III
Quantity
27,517 bottles
Official record key
drug-enforcement:D-0143-2017

Official wording

Reason: Presence of Foreign Tablets/Capsules

Code information: Lot # 0598B151; Exp 03/18

Distribution pattern: US

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets