Partner Therapeutics recalls LEUKINE (sargramostim) 250 mcg vials due to stability failure at 27 months. This may affect patients using the product for cancer treatment.
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Partner Therapeutics is recalling LEUKINE (sargramostim) 250 mcg vials because they failed stability tests at 27 months. This could mean the product might not work properly for cancer treatment patients.
The product failed stability tests at 27 months, meaning it may not be effective for cancer treatment. This could lead to treatment failure if the medication doesn't work as intended.
Patients prescribed LEUKINE for cancer treatment who have the specific vial size and lot number. Those using the product without a doctor's prescription are not affected.
Check for LEUKINE (sargramostim) 250 mcg vials in 5mL size, 5 vials per box, with lot number E8023E and expiration date 11/30/2022. This product is only available by prescription.
Verify the lot number and expiration date on the vial packaging to confirm if it matches the recalled batch.
The product failed stability tests at 27 months, so it may not be effective for cancer treatment. Patients should not use it without consulting their doctor.
Check the lot number and expiration date. If it matches the recalled batch (lot E8023E, exp. 11/30/2022), contact your doctor to discuss alternatives.
No, only the specific vial size (250 mcg/5mL), 5 vials per box, with lot number E8023E and expiration date 11/30/2022.
We’ve drafted a message you can send Partner Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall D-0655-2021 — Partner Therapeutics Partner Therapeutics Hello, I own a Partner Therapeutics that is covered by recall D-0655-2021 from Partner Therapeutics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
