Lynnwood, WA, United States
Partner Therapeutics Inc recalls
1 recall recorded since 2018, most recently on 23 June 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 23 June 2021
- Terminated
- 7 February 2023
- Reason
- 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)
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0655-2021
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.