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 the assurance of sterility.
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-of-harm product (injection) where injury has not yet been reported, and the agency classification is Class II without explicit hospitalization reports.
Plain-English summary
Nora Apothecary and Alternative Therapies, Inc. is recalling Trimix Inj 4.25ml Form MDV 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 distribution pattern is listed as nationwide.
The recall was initiated due to FDA inspection findings that resulted in concerns regarding quality control processes and a lack of assurance of sterility. The source text does not specify the number of affected units or report any illnesses or injuries.
Consumers should stop using the recalled product and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration,
- Manufacturer
- Nora Apothecary and Alternative Therapies, Inc.
- Category
- Drug — Injectable Medication
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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