Drug product
Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
D-0004-2017
Product summary
- Event
- Event 75212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 247.5 mL total volume
- Official record key
drug-enforcement:D-0004-2017
Official wording
Reason: Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Code information: 07252016@22 BUD 09/22/2016; 08102016@28 BUD 10/08/2016
Distribution pattern: Oklahoma
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility