Class II · Moderate risk Terminated
Hylenex recombinant
Reason cGMP Deviations: Temperature excursion
Hyaluronidase
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 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 3321678359
- Recalling firm
- KRS Global Biotechnology, Inc
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0060-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Hyaluronidase recalls
See all
Class II · Moderate risk Terminated
Lidocaine HCL / Bupivacaine HCL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
LIDOcaine 2%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
S-Hyaluronidase 150u/Ml Inj Soln
Reason Lack of Assurance of Sterility
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.