Martin Avenue Pharmacy Recalls Hydroxocobalamin Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Hydroxocobalamin 5 mg/mL injectable vials due to quality control issues that may affect 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 drug, which is a high-risk product category. The source text does not report any illnesses or injuries, and the agency classification is Class II, fitting the criteria for a High severity score (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Hydroxocobalamin 5 mg/mL injectable packaged in amber glass vials. The affected product is identified by Lot Number 07232014@25 and has an expiration date of 10/21/2014. The recall covers all compounded sterile preparations within their expiry dates.
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 affected product is listed as nationwide.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be discontinued from use and returned to the pharmacy or disposed of according to local regulations. No specific instructions for consumer action beyond identifying the affected lot are provided in the source text.
The recalled product
- Product
- Hydroxocobalamin 5 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: 07232014@25
- Exp 10/21/2014
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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