Martin Avenue Pharmacy Recalls Hydroxyzine Hydrochloride Injectable Vials
Martin Avenue Pharmacy is voluntarily recalling Hydroxyzine hydrochloride 25 mg/mL injectable vials due to quality control observations that present a risk to 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 where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry date. The specific product identified is Hydroxyzine hydrochloride 25 mg/mL injectable packaged in an amber glass injectable vial, 10 mL quantity. The recall is initiated in connection with a recent FDA inspection.
The recall is due to observations associated with certain quality control procedures that present a risk to sterility assurance. The source text does not specify the number of units affected or report any illnesses or injuries.
Consumers and healthcare providers should stop using the recalled product and contact Martin Avenue Pharmacy, Inc. for further instructions or a replacement.
The recalled product
- Product
- Hydroxyzine hydrochloride 25 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: 08192014@51
- Exp 11/17/2014
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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