PlainRecalls
FDA Drug Moderate Class II Terminated

Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335

Reported: October 9, 2019 Initiated: September 12, 2019 #D-0115-2020

Product Description

Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
948 vials
Distribution
Nationwide
Location
Boca Raton, FL

Frequently Asked Questions

What product was recalled?
Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335. Recalled by KRS Global Biotechnology, Inc. Units affected: 948 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on October 9, 2019. Severity: Moderate. Recall number: D-0115-2020.