Martin Avenue Pharmacy Recalls Histamine Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Histamine 0.55 mg/mL injectable vials because quality control observations during an FDA inspection raised concerns about 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 measure based on quality control observations regarding sterility assurance, with no reported illnesses or injuries.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry date. This action includes Histamine 0.55 mg/mL injectable packaged in amber glass vials, specifically Lot Number 08142014@27 with an expiration date of 9/13/2014. 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 preparations.
Consumers and healthcare providers should stop using the recalled product and contact Martin Avenue Pharmacy, Inc. for further instructions or a replacement. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Histamine 0.55 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: 08142014@27
- Exp 9/13/2014
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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