The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-494-2013·Announced 2013-06-05

Nora Apothecary Recalls Meperidine Injection Due to Sterility Concerns

Nora Apothecary is recalling Meperidine 100mg/ml MDV, 5ml vials 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, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks such as lack of sterility assurance.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling Meperidine 100mg/ml MDV, 5ml 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 distribution pattern is listed as nationwide.

The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes. Specifically, there is a lack of assurance of sterility for the affected products. The agency classification for this recall is Class II.

Consumers and healthcare providers should stop using the recalled Meperidine 100mg/ml MDV, 5ml vials and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Meperidine 100mg/ml MDV, 5ml 90 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Injectable Medication
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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