Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419
Reported: October 9, 2019 Initiated: September 12, 2019 #D-0066-2020
Product Description
Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- KRS Global Biotechnology, Inc
- Units Affected
- 6405 syringes
- Distribution
- Nationwide
- Location
- Boca Raton, FL
Frequently Asked Questions
What product was recalled? ▼
Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419. Recalled by KRS Global Biotechnology, Inc. Units affected: 6405 syringes.
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-0066-2020.
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