The Recall Desk
SevereFDA (Drugs)·D-484-2013·Announced 2013-06-05

Nora Apothecary Recalls Methylcobalamin Injections Due to Sterility Concerns

Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin 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 infection.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Inj 5mg/ml MDV in 5 ml, 10 ml, 12 ml, and 20 ml vials. The recall was initiated following FDA inspection findings that raised concerns regarding the company's quality control processes and a lack of assurance of sterility.

The recall affects 11 units of the product distributed nationwide. The specific products involved are those 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 the recalled product and contact the recalling firm for further instructions or a refund.

The recalled product

Product
Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Injectable
Hazard
Affected units
11

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

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