Vitamin 10 B Lyophilized Vial (KRS Global) - Labeling Error (2017)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Brand
KRS Global Biotechnology, Inc
Lot Codes / Batch Numbers
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
Products Sold
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
KRS Global Biotechnology, Inc is recalling Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce B due to Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026