Class II · Moderate risk Terminated
Hylenex recombinant
Reason cGMP Deviations: Temperature excursion
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
What was recalled
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Recalling firm
- Guardian Pharmacy Services
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1059-2018
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
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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
Hyaluronidase
Reason Lack of Assurance of Sterility
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