The Recall Desk
SevereFDA (Drugs)·D-482-2013·Announced 2013-06-05

Nora Apothecary Recalls Hydroxycobalamin Injection Due to Sterility Concerns

Nora Apothecary and Alternative Therapies, Inc. is recalling Hydroxycobalamin Injection 2500 mcg/ml 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. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterility concerns which pose significant health risks.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling Hydroxycobalamin Injection 2500 mcg/ml, a subcutaneous medication with a 90-day expiration. The recall is being conducted because FDA inspection findings resulted in concerns regarding quality control processes and a lack of assurance of sterility.

The recall includes all products within their expiration date, specifically those dated 90 days prior to April 19, 2013 (January 2013 to April 19, 2013). The distribution pattern for these products is nationwide.

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 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 →

Related recalls

Same manufacturer · Nora Apothecary and Alternative Therapies, Inc.

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Same hazard · sterility concern

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