Nora Apothecary Recalls Bimix Inj 30:0.5 MDV Penile Injection
Nora Apothecary and Alternative Therapies, Inc. is recalling Bimix Inj 30:0.5 MDV Penile Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly given the risk of non-sterile medical products.
Plain-English summary
Nora Apothecary and Alternative Therapies, Inc. is recalling Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection. The recall covers all products within their expiration date, including those dated 90 days prior to April 19, 2013 (January 2013 to April 19, 2013). The product was distributed nationwide.
The recall was initiated due to FDA inspection findings that resulted in concerns regarding quality control processes. Specifically, there is a lack of assurance of sterility for the affected products.
Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration,
- Manufacturer
- Nora Apothecary and Alternative Therapies, Inc.
- Category
- Drug — Injectable
- Affected units
- 5
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)
- 2013 (Jan. 2013 to April 19
- 2013).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 43 recalled by Nora Apothecary and Alternative Therapies, 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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