June 2021 FDA Recall Leukine by Partner Therapeutics Inc
D-0655-2021 - FAILED STABILITY SPECIFICATION
This Class III drug recall was voluntarily initiated by Partner Therapeutics Inc on June 23, 2021 for the product Leukine. The FDA reported the reason for recall as failed stability specification. The product was distributed in Product was distributed to one government account (ASPR) and the recall is currently terminated.
Recall Number: D-0655-2021
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
06-23-2021
07-21-2021
32,260 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Partner Therapeutics Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to one government account (ASPR)
02-07-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : E8023E, exp. date 11/30/2022
