The Recall Desk
SevereFDA (Drugs)·D-1103-2014·Announced 2014-03-12

Cyanocobalamin Injection Recalled for Sterility Assurance Concerns

Natures Pharmacy & Compounding Center is recalling all lots of Cyanocobalamin 100mcg/ml injection due to quality control issues affecting sterility assurance.

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 source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as sterility assurance failures in injectable products.

Plain-English summary

Natures Pharmacy & Compounding Center is recalling all lots of Cyanocobalamin 100mcg/ml injection that are not expired. The recall is limited to products distributed in North Carolina (NC).

The recall was initiated due to concerns regarding quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection of the pharmacy's sterile compounding processes.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Cyanocobalamin 100mcg/ml injection

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 (1)

  • All lot numbers within expiry.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 48 recalled by Natures Pharmacy & Compounding Center 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 48 products in this recall →