Agency classClass IOur severity:Critical FDA (Drugs)·D-1551-2020·Announced 2020-09-02

SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination

SCA Pharmaceuticals is recalling 366 containers of Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL due to cross-contamination with undeclared benzyl alcohol.

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 recall is classified as FDA Class I, which meets the criteria for a Critical severity score (5) according to the rubric.

Plain-English summary

SCA Pharmaceuticals is recalling 366 containers of Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL). The affected product is identified by NDC#: 70004-0650-44, Bar Code 70004065044, Lot #: 1220019289, and an expiration date of 08/21/2020. The recall was initiated because the containers were labeled as containing methylparaben and propylparaben as preservatives, but actually contained undeclared benzyl alcohol and did not contain any parabens.

The affected product was distributed nationwide within the U.S. This recall is classified as Class I by the U.S. Food and Drug Administration. The source text does not specify the number of reported illnesses or injuries associated with this recall.

Consumers and healthcare providers should stop using the affected product and contact SCA Pharmaceuticals or their healthcare provider for further instructions. The recall is limited to the specific lot number and expiration date listed above.

The recalled product

Product: 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#: 70004-0650-44, Bar Code 70004065044.
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injection
Hazard: undeclared-ingredient
cross-contamination
Affected units: 366

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 #: 1220019289
Exp 08/21/2020.

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

See all →

High
SCA Pharmaceuticals Fentanyl-Bupivacaine Injectable Recall Due to Manufacturing Deviations
FDA (Drugs) · 2023-08-02
Moderate
FDA recalls Oxytocin product for low potency nationwide
FDA (Drugs) · 2023-05-03
Moderate
Fentanyl Injection Syringes Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2023-03-08
Moderate
Norepinephrine Injection Recalled Nationwide for Manufacturing Quality Deviations
FDA (Drugs) · 2022-05-11
Moderate
Drug recall: fentanyl and bupivacaine injectable solution manufacturing deviations
FDA (Drugs) · 2022-05-11

Same hazard · undeclared ingredient