Drug product
Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88887-6795-01
D-0140-2018
Product summary
- Event
- Event 78678
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0140-2018
Official wording
Reason: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Code information: Lot, exp: 170627-012, 9/25/2017; 170629-019, 9/27/2017
Distribution pattern: SSM Health entities in the state of MO only
Derived failure modes
-
Microbial contamination
Microbial growth
-
Sterility assurance
Lack of sterility