The Recall Desk
ModerateFDA (Drugs)·D-0516-2016·Announced 2015-12-16

RemedyRepack Recalls Novolin 70/30 Vials Due to Incorrect Storage Instructions

RemedyRepack Inc. is recalling 106 vials of Novolin 70/30 insulin because the packaging contains incorrect storage instructions.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect storage instructions) without reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.

Plain-English summary

RemedyRepack Inc. is recalling 106 vials of Novolin 70/30, 100 Units/mL Solution. The product was originally manufactured by Novo Nordisk, A/S and repackaged by RemedyRepack Inc. The recall was initiated because the product labeling contains incorrect storage instructions.

The affected product is identified by NDC 52125-0414-01. Specific lot numbers and expiration dates include QM114CZF0496 (Exp 01/2016), B0025373-050514 (Exp 02/2016), B0029738-060914 (Exp 02/2016), and B0029737-060914 (Exp 03/2016). The recall is classified as Class II by the FDA.

The source text does not specify the geographic distribution of the recalled units or provide specific instructions for consumers on how to return the product. Patients using this medication should consult their healthcare provider regarding the recall and proper storage of their insulin.

The recalled product

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
Manufacturer
RemedyRepack Inc.
Affected units
106

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by RemedyRepack Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →