Hylenex recombinant recall: CGMP Deviations
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
Why was Hylenex recombinant recalled?
cGMP Deviations: Temperature excursion
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial # 100000831961 100000820688 100000820689 100000820515
- 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
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Quantity
- 5 cartons/20 units each carton
- Distribution
- Virgina
- Recall date
- December 18, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)