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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Category
- Drug — Insulin
- Hazard
- 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.
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