The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-462-2013·Announced 2013-06-05

Nora Apothecary Recalls Trimix Penile Injection Due to Sterility Concerns

Nora Apothecary is recalling 72 units of Trimix Penile Injection nationwide due to FDA inspection findings regarding quality control and lack of assurance of sterility.

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 3/5 (High).

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 sterile medical injection where the lack of assurance of sterility poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling 72 units of Trimix Inj 30:1:20 MDV Penile Injection. The affected products are available in 5 ml, 10 ml, and 2x5 ml vials with 30 and 90-day expiration dates. The recall is distributed nationwide.

The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes and a lack of assurance of sterility. The source text does not specify reported illnesses or injuries associated with the use of these products.

Consumers who possess these products should stop using them and contact the recalling firm for further instructions. 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 recalled product

Product
Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
72

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.

See all 43 products in this recall →

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