FDA Drug recall D-1495-2020
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…
- FDA Drug
- Class II
- terminated
- Published 2020-08-19
On 2020-08-19 the FDA classified a Class II recall of 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… by Sca Pharmaceuticals, citing subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1495-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-29 |
| Published | 2020-08-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sca Pharmaceuticals |
| Distribution | US |
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
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Identifiers
| code_info | Lot #: 1220018755, Exp. Date 7/30/2020; 1220018861, 1220018850, Exp. Date 8/4/2020; 1220018899, Exp. Date 8/5/2020;…Lot #: 1220018755, Exp. Date 7/30/2020; 1220018861, 1220018850, Exp. Date 8/4/2020; 1220018899, Exp. Date 8/5/2020; 1220019027, Exp. Date 8/11/2020; 1220019075, Exp. Date 8/12/2020; 1220019243, Exp. Date 8/20/2020; 1220019439, 1220019279, 1220019392, Exp. Date 8/24/2020; 1220019488, Exp. Date 8/26/2020 |
|---|
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-1495-2020%22
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