HEPERAIN 50 mg/50 mL — Class II drug recall D-0430-2019
Terminated recall by Advanced Pharma Inc., reported 2019-01-30, distributed in TX, WA. Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL
| Recall number | D-0430-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Pharma Inc., Houston, TX, United States |
| Recall initiated | 2019-01-15 |
| Classified | 2019-02-08 |
| Reported by FDA | 2019-01-30 |
| Terminated | 2019-05-01 |
| Distributed | TX, WA |
| Quantity | 160 syringes |
| Reason classes | labeling, potency |
| NDC | 42852-0725-65 |
| Lot numbers | 0242, 72565S |
| Expiration dates | 2019-03-31 |
Product
HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syringe, Avella of Houston an FDA Registered 503B Outsourcing Facility 9265 Kirby Dr. Houston, TX 77054 (877) 794-0404 ---- NDC: 42852-725-65
Reason for recall
Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/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-0430-2019. 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.