The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-453-2013·Announced 2013-06-05

Nora Apothecary Recalls Bimix Inj 30:1 Syringes Due to Sterility Concerns

Nora Apothecary is recalling Bimix Inj 30:1 syringes because FDA inspections raised concerns about quality control and sterility assurance.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable products are categorized as Severe.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling Bimix Inj 30:1 Syr penile injection syringes. The recall covers 5 units distributed nationwide. The affected products are those within their expiration date, including those dated 90 days prior to April 19, 2013 (January 2013 to April 19, 2013).

The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the product.

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 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Injectable
Hazard
Affected units
5

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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