Nucala Injection, Solution
FDA Recall NDC 0173-0892
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nucala (NDC 0173-0892). A significant event, classified as Class II, was initiated on Sep 06, 2019 by Glaxosmithkline Llc. The reported reason for this action was: "Temperature Abuse; Product stored and shipped outside of labeled storage requirements."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
September 2019 Class II Recall: Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Recall Number
Class II Terminated
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Sep 06, 2019
Oct 02, 2019
38 syringes
Recall Profile & Regulatory Data
Event ID
83731
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health dba Specialty Pharmaceutical Services
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Oct 08, 2020
Product Description
Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0892-42.
Batch or Lot Expiration Information
Lot# : S25X, Exp. 03/31/21
Affected Packages Involved in this Recall
0173-0881-01Product
0173-0881-61Product
0173-0892-01Product
0173-0892-42Product
0173-0892-61Product
0173-0892-63Product
0173-0904-42Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
