The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0062-2020·Announced 2019-10-09

KRS Global Biotechnology Recalls Hydroxocobalamin Vials Due to Sterility Concerns

KRS Global Biotechnology is recalling 345 vials of Hydroxocobalamin 10 mg/20 mL due to a lack of assurance of sterility. The recall covers all lots remaining within expiry and is 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling 345 vials of Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial. The product is prescription-only and carries the NDC 3321678337. The recall is being conducted because of a lack of assurance of sterility.

The recall covers all lots remaining within their expiry dates. The affected product was distributed nationwide. The source text does not specify specific lot numbers, distribution dates, or the number of units affected beyond the total of 345 vials.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678337
Manufacturer
KRS Global Biotechnology, Inc
Category
Drug — Injectable
Hazard
Affected units
345

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.

See all 80 products in this recall →

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