Drug product
Phosphatidylcholine and Sodium Deoxycholate Injection, all strengths and all presentations including Phospha_Deoxy-35-30-50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-399-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 vials
- Official record key
drug-enforcement:D-399-2013
Official wording
Reason: Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes..
Code information: Lot #: 201303071500JN, Exp 6/7/2013; 1301231000AE, Exp 4/23/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility