D-1552-2020 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
- 1,527 Containers
Product Description
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 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 #: 1220019243, Exp 08/20/2020; 1220019439,1220019279, 1220019392, Exp 08/24/2020; 1220019488, Exp 08/26/2020.