The Recall Desk
SevereFDA (Drugs)·D-495-2013·Announced 2013-06-05

Nora Apothecary Recalls Pyridoxine Injections Due to Sterility Concerns

Nora Apothecary and Alternative Therapies, Inc. is recalling Pyridoxine 100mg/ml Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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 an injectable drug, which poses a significant risk of serious injury or hospitalization if contaminated.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling Pyridoxine 100mg/ml Inj MDV, 1X30 ml, with a 30-day expiration. The recall is being conducted due to FDA inspection findings that raised concerns regarding the company's quality control processes and a lack of assurance of sterility.

The recall covers all products within their expiration date, including those dated 90 days prior to April 19, 2013. This specific timeframe includes products from January 2013 to April 19, 2013. The distribution pattern for these products is listed as nationwide.

Consumers and healthcare providers should stop using the recalled products and contact the recalling firm or their healthcare provider for further instructions on disposal or replacement.

The recalled product

Product
Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration,

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 →