FDA Drug recall D-1023-2019
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:…
- FDA Drug
- Class II
- terminated
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of 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:… by Advanced Pharma, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1023-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-13 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Advanced Pharma |
| Distribution | US |
Product
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
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | 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;…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1023-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.