April 2022 FDA Recall Lansoprazole by Dr. Reddy's Laboratories, Inc.
D-0853-2022 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on April 15, 2022 for the product Lansoprazole. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in OH and the recall is currently terminated.
Recall Number: D-0853-2022
Failed Dissolution Specifications
04-15-2022
05-11-2022
252 Blister Packs
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.
Dr. Reddy's Laboratories, 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.
OH
11-07-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.
Batch or Lot Expiration Information
Lot# : T2000645, Exp 07/2022
