Multi-event July 2022 FDA Recall Lansoprazole by Dr. Reddy's Laboratories, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on July 13, 2022 for the product Lansoprazole. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1288-2022
FAILED DISSOLUTION SPECIFICATIONS
07-13-2022
08-03-2022
2,639 cartons
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.
Nationwide in the USA
12-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856179, NDC 43598-561-78
Batch or Lot Expiration Information
Lot# Lot T2100515, Exp 01/2023
Affected Packages Involved in this Recall
Recall Number: D-1287-2022
FAILED DISSOLUTION SPECIFICATIONS
07-13-2022
08-03-2022
2,892 cartons
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.
Nationwide in the USA
12-06-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856079, NDC 43598-560-78
Batch or Lot Expiration Information
Lot# Lot T2100514, Exp 01/2023
