March 2023 FDA Recall Drug by Teva Pharmaceuticals Usa Inc
D-0510-2023 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa Inc on March 27, 2023 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0510-2023
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
03-27-2023
04-12-2023
3,772 cartons
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.
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.
USA Nationwide
08-23-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
Batch or Lot Expiration Information
Lot# 3007556A, Exp 5/2023
