FDA-Drug2021-07-21Class III
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
Partner Therapeutics Inc
Hazard
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Sold states
Product was distributed to one government account (ASPR)
Affected count
32,260 vials
Manufactured in
2625 162nd St Sw, Lynnwood, WA, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0655-2021Don't want to check this manually?
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