Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: E8023E, exp. date 11/30/2022
Where it was sold
Product was distributed to one government account (ASPR)
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0655-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 23, 2021
- FDA report date
- Jul 21, 2021
- Quantity
- 32,260 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Partner Therapeutics Inc
Original FDA data
Every field from FDA enforcement report D-0655-2021, exactly as published.
Show all FDA fields
- City
- Lynnwood
- State
- WA
- Status
- Terminated
- Country
- United States
- Event ID
- 88164
- Address
- 2625 162nd St Sw
- Code information
- Lot #: E8023E, exp. date 11/30/2022
- Postal code
- 98087-3263
- Report date
- Jul 21, 2021
- Product type
- Drugs
- Recall number
- D-0655-2021
- Classification
- Class III
- Recalling firm
- Partner Therapeutics Inc
- Product quantity
- 32,260 vials
- Termination date
- Feb 7, 2023
- Reason for recall
- FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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)
- Recall initiation date
- Jun 23, 2021
- Initial firm notification
- Center classification date
- Jul 13, 2021