The Recall Desk
SevereFDA (Drugs)·D-487-2013·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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe. While no specific injuries are reported in the text, the lack of assurance of sterility in an injectable drug represents a significant risk of harm, aligning with the Severe criteria for Class II recalls with potential for serious harm.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Inj 25mg/ml Syr (subcutaneous) in 8x0.06ml, 10x0.06ml, and 12x0.06ml syringe configurations. The recall covers 5 units distributed nationwide. The affected products are those within their expiration date, including those dated 90 days prior to April 19, 2013 (January 2013 to April 19, 2013).

The recall was initiated due to FDA inspection findings that resulted in concerns regarding quality control processes. Specifically, there is a lack of assurance of sterility for the affected products.

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

The recalled product

Product
Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Injectable
Hazard
Affected units
5

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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Same manufacturer · Nora Apothecary and Alternative Therapies, Inc.

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Same hazard · sterility

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