Drug product
Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
D-1022-2019
Product summary
- Event
- Event 82398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1575 syringes
- Official record key
drug-enforcement:D-1022-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 10/18/18 1430 87661S Exp. 3/17/2019; 10/29/18 1805 87661S Exp. 3/28/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility