Partner Therapeutics Inc recalls LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Thera
Recalled July 21, 2021 · FDA recall D-0655-2021 · Partner Therapeutics
Hazard
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint. · FDA Class III
Units
32,260 vials
Sold at
Product was distributed to one government account (ASPR)
Description
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Product
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
Manufacturer(s)
Partner Therapeutics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →