Drug product
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
D-055-2013
Product summary
- Firm
- Ameridose LLC
- Event
- Event 63585
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-055-2013
Official wording
Reason: GMP deficiencies
Code information: All lot codes within expiry
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP deficiencies