Heparin Sodium 5 — Class II drug recall D-1495-2020
Terminated recall by SCA Pharmaceuticals, reported 2020-08-19, distributed nationwide. Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
| Recall number | D-1495-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, Windsor, CT, United States |
| Recall initiated | 2020-07-29 |
| Classified | 2020-08-12 |
| Reported by FDA | 2020-08-19 |
| Terminated | 2021-03-17 |
| Distributed | Nationwide (US) |
| Quantity | 3,932 bags |
| Reason classes | potency, specification failure |
| NDC | 70004-0650-46 |
| Lot numbers | 1220018755, 1220018850, 1220018861, 1220018899, 1220019027, 1220019075, 1220019243, 1220019279, 1220019392, 1220019439, 1220019488 |
| Expiration dates | 2020-07-30, 2020-08-04, 2020-08-05, 2020-08-11, 2020-08-12, 2020-08-20, 2020-08-24, 2020-08-26 |
Product
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
Reason for recall
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
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-1495-2020. 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.