Martin Avenue Pharmacy Recalls Hydroxocobalamin Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Hydroxocobalamin 10 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is a voluntary precautionary action based on quality control observations regarding sterility assurance, with no reported illnesses or injuries in the source text.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Hydroxocobalamin 10 mg/mL injectable packaged in amber glass vials. The affected product is identified by Lot Number 07232014@15 and has an expiration date of 10/21/2014. The recall covers all compounded sterile preparations within expiry.
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 products. The distribution pattern for the recalled items is nationwide.
Consumers and healthcare providers should discontinue use of the affected Hydroxocobalamin injectable vials and contact Martin Avenue Pharmacy, Inc. for further instructions or a return.
The recalled product
- Product
- Hydroxocobalamin 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: 07232014@15
- 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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