LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Thera
Summary
The FDA issued a Class III for LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials by Partner Therapeutics Inc. Reason: FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint..
Details
Source
Drug Recall
External ID
D-0655-2021
Action Date
2021-07-21
Status
Terminated
Category
drug
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/Code Info: Lot #: E8023E, exp. date 11/30/2022
Quantity Affected: 32,260 vials
Reason for Recall
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Distribution
Product was distributed to one government account (ASPR)
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-23
Company
Lynnwood, WA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 22 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Partner Therapeutics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Partner Therapeutics Inc have FDA actions?
This is the only FDA action we have on record for Partner Therapeutics Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0655-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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