RemedyRepack Recalls Ascorbic Acid Injection Due to Incorrect Storage Instructions
RemedyRepack Inc. is recalling Ascorbic Acid 500 MG/ML Injection vials because they contain incorrect storage instructions on the label.
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 recall.
Plain-English summary
RemedyRepack Inc. is recalling Ascorbic Acid 500 MG/ML Injection, 50 mL Vials, manufactured by Mylan Institutional and repackaged by RemedyRepack Inc. The recall is due to incorrect storage instructions on the product labeling.
The affected product is identified by NDC 61786-0431-16, Lot # B0105052-100715, and an expiration date of 07/01/2017. The recall is classified as Class II by the FDA.
Consumers and healthcare providers should check their inventory for this specific lot number and stop using the product if it matches the description. The product was distributed nationwide.
The recalled product
- Product
- Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0431-16
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Injectable Medication
- 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 # B0105052-100715
- Exp 07/01/2017
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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