FDAClass IIJanuary 9, 2013

Hyaluronidase 150 u/ml PF recall: Sterility Concern

Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

Why was Hyaluronidase 150 u/ml PF recalled?

Lack of Assurance of Sterility

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?

All lot codes

Product
Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Recalling firm
New England Compounding Center
Quantity
10,865 vials
Distribution
Nationwide
Recall date
January 9, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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