The Recall Desk
SevereFDA (Drugs)·D-485-2013·Announced 2013-06-05

Nora Apothecary Recalls Methylcobalamin Injection Syringes Due to Sterility Concerns

Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin 5mg/ml Injection Syringes 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 risks such as lack of sterility in injectable products are categorized as Severe (Score 4), particularly when structural or quality control defects are identified by the agency.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin 5mg/ml Injection Syringes, 10x0.4syr Subcutaneous, with a 90-day expiration. The recall was initiated following FDA inspection findings that raised concerns regarding the company's quality control processes and the lack of assurance of sterility for the product.

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 for these products is nationwide.

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

The recalled product

Product
Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
2

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 · lack of sterility

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