Why it was recalled
Lack of Assurance of Sterility: All compounded products.
Product description
All sterile drugs compounded between 2/21/14 and 2/24/14.
Lot numbers, UPCs & expiration codes
Expiration dates between 3/5/14 and 3/10/14.
Where it was sold
US: New England
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-0003-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 26, 2014
- FDA report date
- Oct 8, 2014
- Quantity
- 87 Products
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- New England Home Therapies, Inc
Original FDA data
Every field from FDA enforcement report D-0003-2015, exactly as published.
Show all FDA fields
- City
- Southborough
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 67687
- Address
- 337 Turnpike Rd
- Code information
- Expiration dates between 3/5/14 and 3/10/14.
- Postal code
- 01772-1760
- Report date
- Oct 8, 2014
- Product type
- Drugs
- Recall number
- D-0003-2015
- Classification
- Class II
- Recalling firm
- New England Home Therapies, Inc
- Product quantity
- 87 Products
- Termination date
- Aug 17, 2016
- Reason for recall
- Lack of Assurance of Sterility: All compounded products.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- All sterile drugs compounded between 2/21/14 and 2/24/14.
- Distribution pattern
- US: New England
- Recall initiation date
- Feb 26, 2014
- Initial firm notification
- Telephone
- Center classification date
- Oct 1, 2014