Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Inject...
FDA Recall #D-1552-2020 — Class I — July 29, 2020
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.
Recalling Firm
SCA Pharmaceuticals — Windsor, CT
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
1,527 Containers
Distribution
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.