Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including chorionic gonadotropin/mannitol, due to quality control issues affecting 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 is classified as FDA Class II and involves a risk to sterility assurance, which is a significant health hazard, but no specific illnesses or injuries are reported in the source text.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. The recall includes chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar. The company is located at 1247 Rickert Dr, Naperville, IL.
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 affected products. The distribution pattern for these products is nationwide.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. Affected lots include 03222014@5 (Exp 9/18/2014), 04042014@9 (Exp 10/1/2014), 05162014@15 (Exp 11/12/2014), and 07242014@18 (Exp 1/20/2015). Individuals should contact their pharmacist or Martin Avenue Pharmacy for further instructions on how to return or dispose of these products.
The recalled product
- Product
- Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar, 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 (8)
- Lot Number: 03222014@5
- Exp 9/18/2014
- 04042014@9
- Exp 10/1/2014
- 05162014@15
- Exp 11/12/2014
- 07242014@18
- Exp 1/20/2015
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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