Drug product
Procaine Hydrochloride Injection, all strengths and all presentations, including a) Procaine 2% 30 mL PF, b) Procaine HCl 2% 10 mL, c) Procaine HCl 20 mg/mL 30 mL, d) Procaine HCl 1% 50 mL MDV, e) Procaine HCl 1% PF 5 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-401-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 vials
- Official record key
drug-enforcement:D-401-2013
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) 20130405-B, Exp 7/5/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility