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Recall Observatory FDA recall evidence

Drug product

Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0414-01

D-0516-2016

November 11, 2015

Class II

Product summary

Firm
RemedyRepack Inc.
Event
Event 72699
Status
Terminated
Classification
Class II
Quantity
106 Vials
Official record key
drug-enforcement:D-0516-2016

Official wording

Reason: Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.

Code information: LOT#:QM114CZF0496, Exp 01/2016; B0025373-050514, B0029738-060914, Exp 02/2016; B0029737-060914, Exp 03/2016.

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect