Drug product
Triamcinolone Injection, all strengths and all presentations including a) Triamcinolone 40 mg/1 mL PF, b) Triamcinolone Acetonide 45 mg/mL, c) Triamcinolone 50 mg/mL 5 mL PF, d) Triamcinolone 45 mg/mL10 mL, 30 mL, e) Triamcinolone 40 mg/mL SDV PF 1 mL, 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-415-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1423 vials
- Official record key
drug-enforcement:D-415-2013
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) Triamcinolone 40 mg/1 mL PF: 20130314-K, Exp 6/14/2013;b) Triamcinolone Acetonide 45 mg/mL: 20130129-I, Exp 4/29/2013; 20130208-B, Exp 5/8/2013; 20130314-K, Exp 6/14/2013; 20130318-E, Exp 6/18/2013; 20130308-1, Exp 6/8/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility