Drug product
Pfizerpen-G 4.2 MU / SW 240 mL AccuFlo, Packaged in 2 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
D-1194-2015
Product summary
- Firm
- Lincare, Inc.
- Event
- Event 71415
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 Bags
- Official record key
drug-enforcement:D-1194-2015
Official wording
Reason: Lack of Assurance of Sterility: Sterility of product is not assure
Code information: Compounded on 05/29/2015, Discard After: 06/12/2015
Distribution pattern: United States including: Arkansas
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility