Drug product
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
D-1032-2019
Product summary
- Event
- Event 82398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1850 syringes
- Official record key
drug-enforcement:D-1032-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: 11/01/18 8847 80261S Exp. 3/31/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility