Drug product
Hyaluronidase Injection, all strengths and all presentations including a) Hyaluronidase 150u/mL, b) Hyaluronidase 150u/ml 1 mL PF, c) Hyaluronidase 150u/mL PF 1ml SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-371-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 996 vials
- Official record key
drug-enforcement:D-371-2013
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) Hyaluronidaise 150u/mL: 20130205-G, Exp 5/5/2013; b) Hyaluronidase 150u/mL 1 mL PF: 20130321-A, Exp 6/21/2013; c) Hyaluronidase 150u/mL PF 1ml SDV: 20130313-E, Exp 6/13/2013. .
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility