Martin Avenue Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin 25 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. The hazard involves a risk to sterility assurance for an injectable product, which poses a potential risk of harm (infection) even though no specific illnesses or injuries are reported in the source text. This aligns with the 'High' severity 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 25 mg/mL injectable packaged in amber glass vials. The affected product is identified by Lot Number 03262014@24 and has an expiration date of 9/22/2014. The recall covers all compounded sterile preparations within their expiry dates.
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. This lack of assurance of sterility is the primary reason for the recall.
The product was distributed nationwide. Consumers and healthcare providers who possess this specific lot of Methylcobalamin should stop using it and contact Martin Avenue Pharmacy or their healthcare provider for instructions on how to return or dispose of the product.
The recalled product
- Product
- Methylcobalamin 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: 03262014@24
- Exp 9/22/2014
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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