The Recall Desk
ModerateFDA (Drugs)·D-0511-2016·Announced 2015-12-16

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

RemedyRepack, Inc. is recalling 65 vials of Humulin 70/30 insulin due to incorrect storage instructions on the label.

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) with no reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

RemedyRepack, Inc. is recalling 65 vials of Humulin 70/30, 100 Units/mL Injection. The product was originally manufactured by Lilly USA, LLC and repackaged by RemedyRepack, Inc. The recall is being conducted because the product labels contain incorrect storage instructions.

The affected products are identified by the following lot numbers and expiration dates: B0080702-042715 and B0080695-042715 (Exp 07/2017), and B0097444-082015 and B0097443-082015 (Exp 02/2018). The NDC for the product is 52125-0415-08. The recall is classified as Class II by the FDA.

Consumers who have these specific vials should stop using them and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

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
Manufacturer
RemedyRepack Inc.
Affected units
65

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 (6)

  • LOT # B0080702-042715
  • B0080695-042715
  • B0097444-082015
  • Exp 07/2017
  • B0097443-082015
  • Exp 02/2018.

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 →