FDA Drug Class II — Moderate

Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

Hazard

Lack of Assurance of Sterility

Products

Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 7
Brand
Advanced Pharma Inc.
UPC
Lots: 10/24/18 3318 83061S Exp. 3/23/2019; 10/18/18 3354 83061S Exp. 3/17/2019; 10/23/2018 6050 83061S Exp. 3/22/2019; 10/23/18 8105 83061S Exp. 3/22/2019; 10/18/18 1961 83061S Exp. 3/17/2019; 10/18/18 2598 83061S Exp. 3/17/2019; 11/05/18 1184 83061S Exp. 4/4/2019; 10/22/18 0737 83061S Exp. 3/21/2019; 10/25/18 1198 83061S Exp. 3/24/2019; 11/06/18 4451 83061S Exp. 4/5/2019; 11/06/18 0108 83061S Exp. 4/5/2019; 10/22/18 1530 83061S Exp. 3/21/2019

Units Affected

22900 syringes