KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling Hydroxocobalamin 10 mL vials because the company cannot ensure the product is sterile. The recall covers 1,528 units distributed nationwide.
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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile injectable products.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling Hydroxocobalamin 10 mL Vials (5 mg/10 mL) for intramuscular use. The recall is being conducted because the company lacks assurance of the product's sterility. The affected product is identified by NDC 3321678336.
A total of 1,528 units were distributed nationwide. The recall includes all lots remaining within their expiration dates. The product is prescription-only and intended for intramuscular use.
Healthcare providers and patients should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions. Consumers should not use the product if they are unsure of its status.
The recalled product
- Product
- Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678336
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Affected units
- 1,528
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 lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by KRS Global Biotechnology, 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.
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