Why it was recalled
Lack of Assurance of Sterility
Product description
Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Lot numbers, UPCs & expiration codes
All lot codes
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-118-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 26, 2012
- FDA report date
- Jan 9, 2013
- Quantity
- 10,865 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- New England Compounding Center
Original FDA data
Every field from FDA enforcement report D-118-2013, exactly as published.
Show all FDA fields
- City
- Framingham
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 63305
- Address
- 697 Waverly St
- Code information
- All lot codes
- Postal code
- 01702-8589
- Report date
- Jan 9, 2013
- Product type
- Drugs
- Recall number
- D-118-2013
- Classification
- Class II
- Recalling firm
- New England Compounding Center
- Product quantity
- 10,865 vials
- Termination date
- Oct 7, 2016
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 26, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 31, 2012