FDA Drug recall D-1424-2019
Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier…
- FDA Drug
- Class II
- terminated
- Published 2019-07-03
On 2019-07-03 the FDA classified a Class II recall of Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier… by Premier Pharmacy Labs, citing lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can r….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1424-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-18 |
| Published | 2019-07-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Premier Pharmacy Labs |
| Distribution | US |
Product
Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-236-16, barcode 8 69623 23616 2.
Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Identifiers
| code_info | All lots remaining within expiry. |
|---|
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-1424-2019%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.