The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-458-2013·Announced 2013-06-05

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

Nora Apothecary and Alternative Therapies, Inc. is recalling PGE-1 penile injections nationwide due to FDA inspection findings regarding quality control and lack of 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 source text explicitly states the agency classification is Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe).

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is voluntarily recalling 37 units of PGE-1 Inj 20mcg/ml MDV penile injections. The affected products are available in 5ml, 7ml, 10ml, and 20ml multi-dose vials with a 90-day expiration. 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 following FDA inspection findings that resulted in concerns regarding quality control processes. Specifically, the agency identified a lack of assurance of sterility for the product. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased these specific PGE-1 penile injections should stop using them immediately and contact their healthcare provider or the recalling firm for further instructions on disposal or return.

The recalled product

Product
PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Injectable
Hazard
Affected units
37

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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