Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.
Reported: September 2, 2020 Initiated: July 29, 2020 #D-1553-2020
Product Description
Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.
Reason for Recall
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.
Details
- Recalling Firm
- SCA Pharmaceuticals
- Units Affected
- 362 Containers
- Distribution
- Nationwide within the U.S.
- Location
- Windsor, CT
Frequently Asked Questions
What product was recalled? ▼
Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.. Recalled by SCA Pharmaceuticals. Units affected: 362 Containers.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 2, 2020. Severity: Critical. Recall number: D-1553-2020.
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