LEUKINE (Sargramostim) Injection Recalled for Failed Stability Specification
Partner Therapeutics Inc is recalling LEUKINE (sargramostim) for injection due to an out-of-specification result observed at the 27-month stability timepoint. The recall affects 32,260 vials distributed to one government account.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall. No reported illnesses, injuries, or deaths are mentioned in the source text. The hazard is a stability specification failure detected through testing, not an acute or symptomatic risk. Per the severity rubric, FDA Class III recalls are typically scored 1 or 2.
Plain-English summary
Partner Therapeutics Inc is recalling LEUKINE (sargramostim) for injection, 250 mcg/vial, 5 mL vials (Lot #E8023E, expiration date 11/30/2022). A failed stability specification—specifically, an out-of-specification (OOS) result—was observed at the 27-month stability timepoint.
The affected product totals 32,260 vials and was distributed to one government account (ASPR). LEUKINE is a prescription drug administered by intravenous or subcutaneous injection.
Persons who have received this product should consult their healthcare provider. Healthcare providers and patients with questions should contact Partner Therapeutics Inc or the FDA.
The recalled product
- Product
- LEUKINE (SARGRAMOSTIM)
- Brand
- LEUKINE
- Manufacturer
- Partner Therapeutics Inc
- Category
- Drug — Prescription Injection
- Affected units
- 32,260
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: E8023E
- exp. date 11/30/2022
UPCs (1)
- 0371837584354
Distribution
Distribution scope not specified by the agency.
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