The Recall Desk
SevereFDA (Drugs)·D-492-2013·Announced 2013-06-05

Nora Apothecary Recalls M.I.C.+B12 Injections Due to Sterility Concerns

Nora Apothecary and Alternative Therapies, Inc. is recalling M.I.C.+B12 Inj MDV products 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 Severe; while no specific injuries are reported here, the 'lack of assurance of sterility' in an injectable drug represents a significant potential hazard that aligns with the Severe tier for Class II drug recalls where sterility is compromised.

Plain-English summary

Nora Apothecary and Alternative Therapies, Inc. is recalling M.I.C.+B12 Inj MDV products, specifically the 3x50ml and 4x50 ml configurations with a 90-day expiration. 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 is listed as nationwide.

The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes. Specifically, the agency identified a lack of assurance of sterility for the affected products. This is classified as an FDA Class II recall.

Consumers and healthcare providers should stop using the affected M.I.C.+B12 Inj MDV products and contact the recalling firm or their healthcare provider for further instructions on disposal or replacement.

The recalled product

Product
M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration,
Manufacturer
Nora Apothecary and Alternative Therapies, Inc.
Category
Drug — Injectable
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.

See all →

Same hazard · sterility

See all →