Status
Terminated
Drug Enforcement D-054-2013
Lack of assurance of sterility
Classification
Class II
Report Date
November 21, 2012
Termination Date
July 25, 2016
Product Information
- Product description
- All 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
- Product quantity
- —
- Reason for recall
- Lack of assurance of sterility
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Ameridose LLC
- Address
-
201 Flanders Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-054-2013
- Event ID
- 63585
- Recall initiation date
- October 31, 2012
- Center classification date
- November 14, 2012
- Code info
- All lot codes within expiry
- More code info
- —