The Recall Desk
SevereFDA (Drugs)·D-461-2013·Announced 2013-06-05

Nora Apothecary Recalls Trimix Penile Injection Due to Sterility Concerns

Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and sterility assurance.

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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling Trimix Inj 30:1:10 MDV, 5 ml Penile Injection. The recall covers products with 30 and 90-day expiration dates. The distribution pattern is 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 agency classification for this recall is Class II.

Consumers who have this product should stop using it and contact the recalling firm for instructions on return or disposal. The source text does not specify the number of units affected or report any illnesses or injuries.

The recalled product

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

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 →

Related recalls

Same manufacturer · Nora Apothecary and Alternative Therapies, Inc.

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Same hazard · sterility

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