The Recall Desk
LowFDA (Drugs)·D-0655-2021·Announced 2021-07-21

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.

What this means for you

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
Hazard
  • stability-failure
  • out-of-specification

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.

Related recalls

Same category