Why it was recalled
Lack of Assurance of Sterility
Product description
All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
Lot numbers, UPCs & expiration codes
All lot codes
Where it was sold
Nationwide Japan
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-052-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 6, 2012
- FDA report date
- Nov 21, 2012
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- New England Compounding Center
Original FDA data
Every field from FDA enforcement report D-052-2013, exactly as published.
Show all FDA fields
- City
- Framingham
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 63511
- Address
- 697 Waverly St
- Code information
- All lot codes
- Postal code
- 01702-8589
- Report date
- Nov 21, 2012
- Product type
- Drugs
- Recall number
- D-052-2013
- Classification
- Class II
- Recalling firm
- New England Compounding Center
- Termination date
- Oct 7, 2016
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
- Distribution pattern
- Nationwide Japan
- Recall initiation date
- Oct 6, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 14, 2012