FDA Drug recall D-0347-2019
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10…
- FDA Drug
- Class I
- terminated
- Published 2019-01-02
On 2019-01-02 the FDA classified a Class I recall of Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10… by Advanced Pharma, citing labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0347-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-11-29 |
| Published | 2019-01-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Advanced Pharma |
| Distribution | NM, OH, TX |
Product
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
Reason
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Identifiers
| code_info | Lot: 11/01/18 8847 80261S, BUD: 03/31/19 |
|---|
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-0347-2019%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.