Partner Therapeutics Inc: Drug Recall
Recall #D-0655-2021 · 06/23/2021
Class III: Low Risk
Recall Details
- Recall Number
- D-0655-2021
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Partner Therapeutics Inc
- Status
- Terminated
- Date Initiated
- 06/23/2021
- Location
- Lynnwood, WA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,260 vials
Reason for Recall
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
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
Distribution Pattern
Product was distributed to one government account (ASPR)
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.