Phenylephrine HCl — Class II drug recall D-1028-2019
Terminated recall by Advanced Pharma Inc., reported 2019-03-27, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-1028-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Pharma Inc., Houston, TX, United States |
| Recall initiated | 2019-03-13 |
| Classified | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2020-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 800 syringes |
| Reason classes | sterility |
| NDC | 42852-0865-61 |
| Lot numbers | 2976, 86561S |
| Expiration dates | 2019-03-16 |
Product
Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Reason for recall
Lack of Assurance of Sterility
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-1028-2019. 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.