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Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmac...

FDA Recall #D-1495-2020 — Class II — July 29, 2020

Recall #D-1495-2020 Date: July 29, 2020 Classification: Class II Status: Terminated

Product Description

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46

Reason for Recall

Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.

Recalling Firm

SCA Pharmaceuticals — Windsor, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3,932 bags

Distribution

Product was distributed nationwide within the United States.

Code Information

Lot #: 1220018755, Exp. Date 7/30/2020; 1220018861, 1220018850, Exp. Date 8/4/2020; 1220018899, Exp. Date 8/5/2020; 1220019027, Exp. Date 8/11/2020; 1220019075, Exp. Date 8/12/2020; 1220019243, Exp. Date 8/20/2020; 1220019439, 1220019279, 1220019392, Exp. Date 8/24/2020; 1220019488, Exp. Date 8/26/2020

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.

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