Drug product
PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
D-1077-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,494 syringes
- Official record key
drug-enforcement:D-1077-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-270678, 17-270695, Exp. 7/18/2023; 17-270880, Exp. 7/20/2023; 17-271075, Exp. 7/24/2023; 17-271233, 17-271269, Exp. 7/26/2023; 17-271492, 17-271494, Exp. 7/31/2023; 17-271748, Exp. 8/3/2023; 17-271891, Exp. 8/7/2023; 17-271945, Exp. 8/8/2023; 17-272221, 17-272236, Exp. 8/13/2023; 17-272286, 17-272305, Exp. 8/14/2023; 17-272642, Exp. 8/20/2023; 17-272997, 17-272998, Exp. 8/24/2023; 17-273478, 17-273496, 17-273497, Exp. 9/4/2023; 17-274139, 17-274156, 17-274163, Exp. 9/13/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility