The Recall Desk
SevereFDA (Drugs)·D-466-2013·Announced 2013-06-05

Nora Apothecary Recalls Super Trimix Penile Injection Due to Sterility Concerns

Nora Apothecary is recalling Super Trimix #1 Penile Injection 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in an injectable product.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling Super Trimix #1 Inj MDV, a 12 ml penile injection, due to concerns regarding the assurance of sterility. The recall was initiated following FDA inspection findings that raised questions about the manufacturer's quality control processes.

The affected products are distributed nationwide. The recall includes all products within their expiration date, specifically those dated 90 days prior to April 19, 2013, which covers the period from January 2013 to April 19, 2013.

Consumers who have this product should stop using it and contact the manufacturer or their healthcare provider for further instructions on disposal or replacement.

The recalled product

Product
Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Injectable
Hazard
Affected units
1

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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