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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Natures Pharmacy & Compounding Center
- Category
- Drug — Injectable
- Hazard
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.
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