FDAHealthSeptember 11, 2024
Mckesson Medical-Surgical Inc. Corporate Office — Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 1
⚠️ cGMP Deviations: Temperature excursion
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- September 11, 2024
Virgina
What's affected?
- Product
- Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04
- Brand
- HYLENEX RECOMBINANT
- Lot code
- Serial # 100000831961 100000820688 100000820689 100000820515
Additional details
Serial # 100000831961 100000820688 100000820689 100000820515
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5 cartons/20 units each carton.
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