Class III
Terminated
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
- Company
- Partner Therapeutics Inc
- Recall Initiated
- June 23, 2021
- Posted
- July 21, 2021
- Recall Number
- D-0655-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 32,260 vials
- Firm Location
- Lynnwood, WA, United States
Reason for Recall
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Distribution
Product was distributed to one government account (ASPR)
Lot / Code Info
Lot #: E8023E, exp. date 11/30/2022
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