Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin (PF) 25 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 is classified as FDA Class II and involves a risk to sterility assurance for an injectable product, which fits the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Methylcobalamin (PF) 25 mg/mL injectable packaged in amber glass vials. The recall involves Lot Number 04092014@14 with an expiration date of 10/6/2014. The product was distributed nationwide.
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 sterile preparations.
Consumers and healthcare providers should stop using the affected product and contact Martin Avenue Pharmacy or their healthcare provider for further instructions.
The recalled product
- Product
- Methylcobalamin (PF) 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Manufacturer
- Martin Avenue Pharmacy, Inc.
- Category
- Drug — Compounded Injectable
- 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: 04092014@14
- Exp 10/6/2014
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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