FDA Drug recall D-1552-2020
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA…
- FDA Drug
- Class I
- terminated
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class I recall of Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA… by Sca Pharmaceuticals, citing cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1552-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-07-29 |
| Published | 2020-09-02 |
| 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, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.
Reason
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Identifiers
| code_info | Lot #: 1220019243, Exp 08/20/2020; 1220019439,1220019279, 1220019392, Exp 08/24/2020; 1220019488, Exp 08/26/2020. |
|---|
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-1552-2020%22
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