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Recall Observatory FDA recall evidence

Drug product

Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37

D-1286-2015

July 13, 2015

Class III

Product summary

Firm
Perrigo Israel Pharmaceuticals
Event
Event 71765
Status
Terminated
Classification
Class III
Quantity
158,268 tubes
Official record key
drug-enforcement:D-1286-2015

Official wording

Reason: Subpotent drug

Code information: Lot # 063630, Exp 04/16; 069793, Exp 11/16; 071745, Exp 02/17; 076150, Exp 07/17; 081317, Exp 12/17

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent