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Recall Observatory FDA recall evidence

Drug product

Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis, IN 46285, Repackaged by: Remedy Repack, Inc, 625 Kolter Dr, Indiana, PA 15701, NDC 52125-0415-08

D-0511-2016

November 11, 2015

Class II

Product summary

Firm
RemedyRepack Inc.
Event
Event 72699
Status
Terminated
Classification
Class II
Quantity
65 Vials
Official record key
drug-enforcement:D-0511-2016

Official wording

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

Code information: LOT # B0080702-042715, B0080695-042715, B0097444-082015, Exp 07/2017; B0097443-082015, Exp 02/2018.

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect