The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-457-2013·Announced 2013-06-05

Nora Apothecary Recalls PGE-1 Penile Injections Due to Sterility Concerns

Nora Apothecary is recalling PGE-1 Penile Injections because FDA inspections raised concerns about quality control and the 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 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 classification is FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving significant risks such as sterility assurance failures in injectable drugs.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection. The recall covers all products within their expiration date, including those dated 90 days prior to April 19, 2013, which corresponds to products manufactured between January 2013 and April 19, 2013.

The recall was initiated following FDA inspection findings that resulted in concerns regarding the company's quality control processes. Specifically, the FDA identified a lack of assurance of sterility for the affected products.

The distribution pattern for these products is listed as nationwide. Consumers who have these products should stop using them and contact the recalling firm for further instructions.

The recalled product

Product
PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Injectable
Hazard

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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