January 2024 FDA Recall Trandolapril by Glenmark Pharmaceuticals Inc., Usa
D-0259-2024 - Failed Excipient Specifications

This Class II drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on January 4, 2024 for the product Trandolapril. The FDA reported the reason for recall as failed excipient specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0259-2024

Reason for Recall
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Initiated
01-04-2024
Reported
01-31-2024
Quantity
38,496 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93719
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-16-2024
Product Description About Product Description
Full technical description of the product.
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56

Batch or Lot Expiration Information

Lot# : 05220346, 05220369 Exp 1/31/ 2024; 05220582, Exp 2/29/2024; 05220861 Exp 3/31/2024

Affected Packages Involved in this Recall

68462-185-56 Fluocinolone Acetonide