The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-489-2013·Announced 2013-06-05

Nora Apothecary Recalls Renacidin Irrigation Due to Sterility Concerns

Nora Apothecary and Alternative Therapies, Inc. is recalling Renacidin Irrigation bladder irrigation products 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical irrigation product, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling Renacidin Irrigation, a bladder irrigation product available in 1000 ml and 1120 ml sizes. 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 raised concerns regarding the manufacturer's quality control processes. Specifically, the agency identified a lack of assurance of sterility for the affected products.

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

The recalled product

Product
Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Medical Device — Irrigation Solution
Hazard
Affected units
2

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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