Reported Jul 21, 2021 · Terminated
LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner…
Partner Therapeutics Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Partner Therapeutics Inc · 2625 162nd St Sw · Lynnwood, WA · 98087-3263
Is this the product you have?
- 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
- Lot codes and dates
Lot #: E8023Eexp. date 11/30/2022
- Amount recalled
- 32,260 vials
Why it was recalled
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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