Drug product
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48
D-1428-2015
Product summary
- Event
- Event 71892
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 cassettes
- Official record key
drug-enforcement:D-1428-2015
Official wording
Reason: Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
Code information: Lot #: 151900249M, Exp 09/09/15
Distribution pattern: VA, IL, PA, ID
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility