September 2019 FDA Recall Nucala by Cardinal Health Dba Specialty Pharmaceutical Services
D-1876-2019 - Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
This Class II drug recall was voluntarily initiated by Cardinal Health Dba Specialty Pharmaceutical Services on September 6, 2019 for the product Nucala. The FDA reported the reason for recall as temperature abuse; product stored and shipped outside of labeled storage requirements.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1876-2019
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
09-06-2019
10-02-2019
38 syringes
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Cardinal Health dba Specialty Pharmaceutical Services
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S.
10-08-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
