The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0513-2016·Announced 2015-12-16

RemedyRepack Recalls Vitamin B-Complex Injections Due to Labeling Error

RemedyRepack Inc. is recalling Vitamin B-Complex 100 injections because the vials contain 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 moderate severity.

Plain-English summary

RemedyRepack Inc. is recalling specific vials of Vitamin B-Complex 100, Multi MG Inj. The product is manufactured by Mylan Institutional and repackaged by RemedyRepack Inc. The recall involves 30 mL vials with NDC 52125-0873-02.

The recall was initiated because the product labels contain incorrect storage instructions. The source text does not specify the nature of the error or any reported adverse health events. The distribution pattern is listed as nationwide.

Consumers and healthcare providers should check their inventory for the specific lot number B0105037-100715 with an expiration date of 10/01/2016. If found, these products should be returned to the supplier or disposed of according to local regulations.

The recalled product

Product
Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0873-02
Manufacturer
RemedyRepack Inc.
Category
Drug — Injectable Vitamin
Hazard
Affected units
1

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 (2)

  • Lot # B0105037-100715
  • Exp 10/01/2016

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 →

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