Drug product
Nandrolone Decanoate Injection, all strengths and all presentations including a) Nandrolone Decanoate 300 mg/mL, b) Nandrolone 200 mg/mL, c) Nandrolone 250 mg/mL, d) Nandrolone 350 mg/mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-397-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43 vials
- Official record key
drug-enforcement:D-397-2013
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) Nandrolone Decanoate 300 mg/mL: 20130311-J, Exp 6/11/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility