FDA Drug recall D-1020-2019
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 syrin…
- FDA Drug
- Class II
- terminated
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of 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 syrin… by Advanced Pharma, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1020-2019 |
| 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, 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
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | 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…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 |
|---|
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-1020-2019%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.