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.

FDA recall notice · announced September 2, 2020 · Sca Pharmaceuticals

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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.

Notes

Distribution: Nationwide within the U.S.
Lot/code information: Lot #: 1220019457, Exp 08/24/2020
Quantity: 362 Containers
Status: Terminated
Products in this recall event:
- Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 700 (D-1550-2020)
- 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#: 70 (D-1552-2020)
- 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#: 70 (D-1551-2020)
- 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#: (D-1553-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.