Why it was recalled
GMP deficiencies
Product description
All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
Lot numbers, UPCs & expiration codes
All lot codes within expiry
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-055-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 31, 2012
- FDA report date
- Nov 21, 2012
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ameridose LLC
Original FDA data
Every field from FDA enforcement report D-055-2013, exactly as published.
Show all FDA fields
- City
- Westborough
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 63585
- Address
- 201 Flanders Rd
- Code information
- All lot codes within expiry
- Postal code
- 01581-1032
- Report date
- Nov 21, 2012
- Product type
- Drugs
- Recall number
- D-055-2013
- Classification
- Class II
- Recalling firm
- Ameridose LLC
- Termination date
- Jul 25, 2016
- Reason for recall
- GMP deficiencies
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 31, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 14, 2012