Martin Avenue Pharmacy Recalls Cromolyn Sodium Inhalant Solution
Martin Avenue Pharmacy is voluntarily recalling Cromolyn sodium 1% inhalant solution due to sterility assurance concerns identified during an FDA inspection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score (4) under the rubric, particularly given the risk to sterility assurance in a sterile preparation.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Cromolyn sodium 1% inhalant solution packaged in 3 mL or 7 mL vials. The recall covers 190 mL of product distributed nationwide. The specific lot number is 08062014@24, with an expiration date of 11/4/2014.
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 sterile preparations. The recall includes all compounded sterile preparations within their expiry dates.
Consumers who possess this product should stop using it and contact Martin Avenue Pharmacy, Inc. for further instructions or a return. The recall is limited to the specific lot and expiration date listed above.
The recalled product
- Product
- Cromolyn sodium 1% inhalant solution packaged in a 3 mL or 7 mL 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: 08062014@24
- Exp 11/4/2014
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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