Drug 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
D-0655-2021
Product summary
- Event
- Event 88164
- Status
- Terminated
- Classification
- Class III
- Quantity
- 32,260 vials
- Official record key
drug-enforcement:D-0655-2021
Official wording
Reason: FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Code information: Lot #: E8023E, exp. date 11/30/2022
Distribution pattern: Product was distributed to one government account (ASPR)
Derived failure modes
-
Potency or specification failure
Out-of-specification