Phenylephrine HCl — Class I drug recall D-0347-2019
Terminated recall by Advanced Pharma Inc., reported 2019-01-02, distributed in NM, OH, TX. Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather th
| Recall number | D-0347-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Pharma Inc., Houston, TX, United States |
| Recall initiated | 2018-11-29 |
| Classified | 2019-01-07 |
| Reported by FDA | 2019-01-02 |
| Terminated | 2019-05-02 |
| Distributed | NM, OH, TX |
| Quantity | 225 syringes |
| Reason classes | labeling, potency |
| NDC | 42852-0802-61 |
| Lot numbers | 80261S, 8847 |
| Expiration dates | 2019-03-31 |
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 for recall
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".
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0347-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.