Fresenius Kabi Recalls Cyanocobalamin Vials Due to Sterility Concerns
Fresenius Kabi USA is recalling 240,550 vials of Cyanocobalamin Injection due to potential glass fractures and particles that compromise sterility.
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 recall is classified as FDA Class II and involves a risk of serious injury from glass particles in an injectable medication, meeting the criteria for a Severe rating.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 240,550 vials of Cyanocobalamin Injection, USP, 1000 mcg/mL. The affected product is Lot 6003853 with an expiration date of 04/2014. The recall was initiated because the glass vials may have finish fractures and glass particles, which creates a lack of assurance of sterility.
The recalled product is distributed nationwide in the United States, including Puerto Rico. It is a prescription-only medication intended for intramuscular or intravenous use. The product is manufactured by APP Pharmaceuticals, LLC, and packaged by Fresenius Kabi USA, LLC.
Healthcare providers and patients should discontinue use of the affected lot and contact their healthcare provider or the manufacturer for further instructions. Consumers should check their medication vials for the specific lot number and expiration date listed in this recall.
The recalled product
- Product
- CYANOCOBALAMIN (CYANOCOBALAMIN)
- Brand
- CYANOCOBALAMIN
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable Vitamin
- Affected units
- 240,550
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)
- Lot 6003853
- exp. date 04/2014
Distribution
Part of a larger recall action
This product is one of 3 recalled by Fresenius Kabi USA, LLC 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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