Drug product
Dimercapto-propane-sulfonic acid (DMPS) Injection, all strengths and all presentations including a) DMPS 50 mg/5 mL, b) DMPS 50 mg/mL PF 5 mL, c) DMPS Acid 250 mg/5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-359-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 251 vials
- Official record key
drug-enforcement:D-359-2013
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 #: a) DMPS 50 mg/5 mL: 20130326-F, Exp 6/26/2013; b) DMPS 50 mg/mL PF 5 mL: 20130311-A, Exp 6/11/2013; c) DMPS Acid 250 mg/5 mL: 20130130-K, Exp 4/30/2013; 20130212-C, Exp 5/12/2013; 20130311-A, Exp 6/11/2013; 20130308-M, Exp 6/8/2013; 20130130-E, Exp 4/30/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility