Class II · Moderate risk Terminated
Hylenex recombinant
Reason cGMP Deviations: Temperature excursion
Hyaluronidase 150 units/ml Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
What was recalled
Hyaluronidase 150 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
- Recalling firm
- The Compounding Pharmacy of America
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1538-2015
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
Hyaluronidase
Reason Lack of Assurance of Sterility
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