Drug product
Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC: 42852-830-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
D-1020-2019
Product summary
- Event
- Event 82398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16075 syringes
- Official record key
drug-enforcement:D-1020-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 01/18/19 3261 83067S Exp. 6/17/2019; 10/18/18 0212 83067S Exp. 3/17/2019; 10/23/18 7704 83067S Exp. 3/22/2019; 11/02/18 5909 83067S Exp. 4/1/2019; 10/31/18 8995 83067S Exp. 3/30/2019; 10/22/18 2570 83067S Exp. 3/21/2019; 10/18/18 6471 83067S Exp. 3/17/2019; 11/05/18 5527 83067S Exp. 4/4/2019; 11/05/18 0985 83067S Exp. 4/4/2019; 10/22/18 9234 83067S Exp. 3/21/2019; 10/30/18 6678 83067S Exp. 3/29/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility