August 2023 FDA Recall Trandolapril And Verapamil Hydrochloride by Glenmark Pharmaceuticals Inc., Usa
D-1095-2023 - Subpotent
This Class III drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on August 14, 2023 for the product Trandolapril And Verapamil Hydrochloride. The FDA reported the reason for recall as subpotent. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-1095-2023
Subpotent: Out of Specification for Assay Test at the 3-month time point.
08-14-2023
08-30-2023
1,200 bottles
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glenmark Pharmaceuticals Inc., USA
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.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
Batch or Lot Expiration Information
Batch# 19224744
