Drug product
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
D-0003-2017
Product summary
- Event
- Event 75212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 455 mL total volume
- Official record key
drug-enforcement:D-0003-2017
Official wording
Reason: Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Code information: 05162016@18 BUD 09/13/2016; 07052016@9 BUD 11/02/2016; 08032016@13 BUD 12/01/2016
Distribution pattern: Oklahoma
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility