Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin (PF) 1 mg/mL injectable vials due to quality control issues that may compromise sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk to sterility assurance in injectable products, which poses a risk of harm (infection) even though no specific illnesses or injuries are reported in the source text.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Methylcobalamin (PF) 1 mg/mL injectable packaged in amber glass vials. The affected product is identified by Lot Number 05082014@15 and has an expiration date of 11/4/2014. The recall covers 100 mL quantities distributed nationwide.
The recall was initiated following an FDA inspection that identified observations associated with certain quality control procedures. These issues present a risk to the assurance of sterility for the compounded sterile preparations. The agency classification for this recall is Class II.
Consumers and healthcare providers should stop using the affected product and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for further instructions on disposal or replacement.
The recalled product
- Product
- Methylcobalamin (PF) 1 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Manufacturer
- Martin Avenue Pharmacy, Inc.
- Hazard
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 Number: 05082014@15
- Exp 11/4/2014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Martin Avenue Pharmacy, 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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