FDA Recall D-1553-2020
SCA Pharmaceuticals · Windsor, CT
Class I — life-threatening Terminated 296 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-1553-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the U.S.
- Recall initiated
- 2020-07-29
- Classified by FDA Center
- 2020-08-27
- FDA published
- 2020-09-02
- Terminated
- 2021-05-21
- Recalling firm
- SCA Pharmaceuticals
- Firm location
- Windsor, CT