D-1551-2020 Class I Terminated
FDA drug recall D-1551-2020 was initiated by SCA Pharmaceuticals on July 29, 2020 and is designated Class I. 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. The recall status is terminated (terminated May 21, 2021). Affected quantity: 366 Containers.
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.