D-0655-2021 Class III Terminated
FDA drug recall D-0655-2021 was initiated by Partner Therapeutics Inc on June 23, 2021 and is designated Class III. Reason for recall: FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint. The recall status is terminated (terminated February 7, 2023). Affected quantity: 32,260 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 21, 2021
- Initiation Date
- June 23, 2021
- Termination Date
- February 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,260 vials
Product Description
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
Reason for Recall
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Distribution Pattern
Product was distributed to one government account (ASPR)
Code Information
Lot #: E8023E, exp. date 11/30/2022