Class II · Moderate risk Terminated
Hylenex recombinant
Reason cGMP Deviations: Temperature excursion
Hyaluronidase Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
What was recalled
Hyaluronidase Injection, all strengths and all presentations including a) Hyaluronidase 150u/mL, b) Hyaluronidase 150u/ml 1 mL PF, c) Hyaluronidase 150u/mL PF 1ml SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Recalling firm
- FVS Holdings, Inc. dba. Green Valley Drugs
- Origin
- NV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-371-2013
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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