Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin 1 mg/mL injectable vials because quality control observations during an FDA inspection raised concerns about 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 fits the rubric criterion 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 1 mg/mL injectable packaged in amber glass vials. The recall covers all compounded sterile preparations within their expiry dates. The affected product was distributed nationwide.
The recall was initiated following a recent FDA inspection. During the inspection, observations were made regarding certain quality control procedures that present a risk to sterility assurance. The source text does not report any specific illnesses or injuries associated with the use of these products.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The recall includes specific lot numbers and expiration dates as identified in the structured product information.
The recalled product
- Product
- Methylcobalamin 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 (4)
- Lot Number: 03212014@22
- Exp 9/17/2014
- 05222014@19
- Exp 11/18/2014
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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