Agency classClass IOur severity:Critical FDA (Drugs)·D-1553-2020·Announced 2020-09-02

SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination

SCA Pharmaceuticals is recalling Heparin Sodium 10,000 units injection containers due to cross contamination with undeclared benzyl alcohol and missing parabens.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5) regardless of other factors.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 362 containers of Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use. The affected product is identified by NDC 70004-0652-46, Lot # 1220019457, and an expiration date of 08/24/2020. The recall was initiated due to cross contamination with other products.

The recall is necessary because the containers were labeled as containing methylparaben and propylparaben as preservatives, but they actually contained undeclared benzyl alcohol and did not contain any parabens. This discrepancy represents a significant labeling and content error for a prescription medication intended for intravenous use.

The affected units were distributed nationwide within the U.S. Healthcare facilities and patients who have received or are using this specific lot of Heparin Sodium should contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

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.
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injection
Hazard: undeclared-ingredient
mis-labeling
Affected units: 362

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: 1220019457
Exp 08/24/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by SCA Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · SCA Pharmaceuticals

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