Recalls / Class III
Class IIID-0655-2021
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
- Brand name
- Leukine
- Generic name
- Sargramostim
- Active ingredient
- Sargramostim
- Route
- Intravenous, Subcutaneous
- NDC
- 71837-5843
- FDA application
- BLA103362
- Affected lot / code info
- Lot #: E8023E, exp. date 11/30/2022
Why it was recalled
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Recalling firm
- Firm
- Partner Therapeutics Inc
- Manufacturer
- Partner Therapeutics, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 2625 162nd St Sw, Lynnwood, Washington 98087-3263
Distribution
- Quantity
- 32,260 vials
- Distribution pattern
- Product was distributed to one government account (ASPR)
Timeline
- Recall initiated
- 2021-06-23
- FDA classified
- 2021-07-13
- Posted by FDA
- 2021-07-21
- Terminated
- 2023-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0655-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.