Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin 10 mg/mL injectable vials due to quality control observations that present a risk to 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 involves a risk to sterility assurance for an injectable product, which is a high-risk hazard where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Methylcobalamin 10 mg/mL injectable packaged in amber glass vials. The affected product is identified by Lot Number 06072014@1 and has an expiration date of 12/4/2014. The recall covers all compounded sterile preparations within their expiry date.
The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These observations present a risk to the assurance of sterility for the compounded preparations. The distribution pattern for the recalled product is listed as nationwide.
Consumers and healthcare providers should stop using the affected Methylcobalamin injectable vials immediately. The source text does not specify a contact number or specific return instructions for the recalled product.
The recalled product
- Product
- Methylcobalamin 10 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: 06072014@1
- Exp 12/4/2014
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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