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Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-...

FDA Recall #D-0516-2016 — Class II — November 11, 2015

Recall #D-0516-2016 Date: November 11, 2015 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

RemedyRepack Inc. — Indiana, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

106 Vials

Distribution

Nationwide

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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