Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

LEUKINE (Sargramostim) for Injection Recalled by Partner Therapeutics Inc Due to FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for...

Date: June 23, 2021
Company: Partner Therapeutics Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Partner Therapeutics Inc directly.

Affected Products

LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Therapeutics, Inc. Lexington, MA 02421, NDC 71837-5843-5

Quantity: 32,260 vials

Why Was This Recalled?

FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.

Where Was This Sold?

Product was distributed to one government account (ASPR)

About Partner Therapeutics Inc

Partner Therapeutics Inc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report