Drug product
All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
D-0231-2015
Product summary
- Event
- Event 65953
- Status
- Terminated
- Classification
- Class II
- Quantity
- Undetermined
- Official record key
drug-enforcement:D-0231-2015
Official wording
Reason: Lack of Assurance of Sterility
Code information: ALL lots of product on the market as of August 9, 2013.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility