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
Reported: July 21, 2021 Initiated: June 23, 2021 #D-0655-2021
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.
Details
- Recalling Firm
- Partner Therapeutics Inc
- Units Affected
- 32,260 vials
- Distribution
- Product was distributed to one government account (ASPR)
- Location
- Lynnwood, WA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Partner Therapeutics Inc. Units affected: 32,260 vials.
Why was this product recalled? ▼
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 21, 2021. Severity: Low. Recall number: D-0655-2021.
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