Agency classClass IOur severity:Critical FDA (Drugs)·D-1552-2020·Announced 2020-09-02

SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination

SCA Pharmaceuticals is recalling Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL single-dose containers 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 agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors, as it indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 1,527 containers of Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL). The product is identified by NDC# 70004-0650-46 and Bar Code 70004065046. The affected lots are 1220019243 (Exp 08/20/2020), 1220019439, 1220019279, and 1220019392 (Exp 08/24/2020), and 1220019488 (Exp 08/26/2020).

The recall was initiated due to cross-contamination with other products. Specifically, containers labeled as containing methylparaben and propylparaben as preservatives were found to actually contain undeclared benzyl alcohol and did not contain any parabens. This discrepancy represents a significant labeling and formulation error for a prescription-only intravenous medication.

The affected product was distributed nationwide within the U.S. Healthcare providers and patients should check their inventory for the specific NDC, lot numbers, and expiration dates listed above. If the product is found, it should be quarantined and not administered. SCA Pharmaceuticals is the recalling firm responsible for managing this recall.

The recalled product

Product: 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.
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injection
Hazard: undeclared-ingredient
cross-contamination
mis-labeling
Affected units: 1,527

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 (8)

Lot #: 1220019243
Exp 08/20/2020
1220019439
1220019279
1220019392
Exp 08/24/2020
1220019488
Exp 08/26/2020.

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