The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-491-2013·Announced 2013-06-05

Nora Apothecary Recalls Glutathione Injections Due to Sterility Concerns

Nora Apothecary is recalling Glutathione 200mg/ml 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant risks such as sterility issues in injectable drugs are categorized as Severe (Score 4), particularly when structural or process defects are identified by the agency.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling Glutathione 200mg/ml Inj SDV products. The recall covers 3x50ml vials with a 14-day expiration and 1x50ml vials with a 21-day expiration. The products were distributed nationwide.

The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes. Specifically, the agency identified a lack of assurance of sterility in the manufacturing or handling of these products.

The recall includes all products within their expiration date, including those dated 90 days prior to April 19, 2013 (January 2013 to April 19, 2013). Consumers and healthcare providers should stop using these products and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Injectable
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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