KRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Labeling Errors
KRS Global Biotechnology is recalling 5,786 vials of Vitamin 10 B Lyophilized Vial due to incorrect or missing lot and expiration dates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves minor labeling errors regarding lot and expiration dates, which fits the criteria for a moderate severity recall.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 5,786 vials of Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only. The recall was initiated because the product has incorrect or missing lot and/or expiration dates. Specifically, the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product.
The affected product was distributed nationwide in the USA, Bermuda, and New Zealand. The recall covers specific lots with Beyond Use Dates ranging from November 19, 2017, to April 11, 2018.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Vitamin
- Hazard
- Affected units
- 5,786
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 (12)
- Lots
- 05232017@13 BUD: 11/19/2017
- 05262017@2 BUD: 11/22/2017
- 06022017@1 BUD: 11/29/2017
- 06092017@1 BUD: 12/6/2017
- 06162017@10 BUD: 12/13/2017
- 08142017@10 BUD: 2/10/2018
- 08252017@1 BUD: 2/21/2018
- 09222017@1 BUD: 3/21/2018
- 09292017@1 BUD: 3/28/2018
- 10062017@1 BUD: 4/4/2018
- 10132017@2 BUD: 4/11/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 47 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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