July 2023 FDA Recall Sunitinib Malate by Teva Pharmaceuticals Usa Inc
D-0913-2023 - Failed Moisture Limits
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa Inc on July 5, 2023 for the product Sunitinib Malate. The FDA reported the reason for recall as failed moisture limits. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0913-2023
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
07-05-2023
07-19-2023
180 bottles
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.
Teva Pharmaceuticals USA 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
01-10-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Batch or Lot Expiration Information
Lot# 100037220, Exp 10/2024
