D-1551-2020 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 2, 2020
- Initiation Date
- July 29, 2020
- Termination Date
- May 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 366 Containers
Product Description
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044.
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.
Distribution Pattern
Nationwide within the U.S.
Code Information
Lot #: 1220019289, Exp 08/21/2020.