Nora Apothecary Recalls Trimix Penile Injections Due to Sterility Concerns
Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks such as sterility assurance failures in injectable drugs.
Plain-English summary
Nora Apothecary and Alternative Therapies, Inc. is recalling Trimix Inj 30:1:40 MDV, 5 ml Penile Injection. The recall covers products with expiration dates ranging from January 2013 to April 19, 2013. The distribution pattern is listed as nationwide.
The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and a lack of assurance of sterility. The source text does not report any specific illnesses or injuries associated with these products.
Consumers who possess these products should stop using them and contact the recalling firm or their healthcare provider for instructions on how to proceed.
The recalled product
- Product
- Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
- Manufacturer
- Nora Apothecary and Alternative Therapies, Inc.
- Category
- Drug — Injectable
- 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)
- 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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