Drug 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.
D-1553-2020
Product summary
- Event
- Event 86193
- Status
- Terminated
- Classification
- Class I
- Quantity
- 362 Containers
- Official record key
drug-enforcement:D-1553-2020
Official wording
Reason: 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.
Code information: Lot #: 1220019457, Exp 08/24/2020
Distribution pattern: Nationwide within the U.S.
Derived failure modes
-
Unknown
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.