D-0737-2022 Class II Terminated

Recalled by Dr. Reddy's Laboratories, Inc. — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
April 6, 2022
Initiation Date
March 23, 2022
Termination Date
February 2, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,352 bottles (30-count), 1,368 bottles (90-count)

Product Description

Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India

Reason for Recall

Failed Dissolution Specifications; during long term stability testing.

Distribution Pattern

Nationwide in the USA

Code Information

Lot # a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023.