The Recall Desk
SevereFDA (Drugs)·D-455-2013·Announced 2013-06-05

Nora Apothecary Recalls Bimix Inj Penile Injection Due to Sterility Concerns

Nora Apothecary is recalling Bimix Inj 30:1 MDV 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 product, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling 128 units of Bimix Inj 30:1 MDV penile injections. The affected products are available in 5ml, 10ml, 3x10ml, and 2x10ml vials with 30 and 90-day expiration dates. 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 products were distributed nationwide.

The recall was initiated due to FDA inspection findings that resulted in concerns regarding quality control processes and the lack of assurance of sterility. The agency classification for this recall is Class II.

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

The recalled product

Product
Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Injectable
Hazard
Affected units
128

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 concern

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