FDA Drug Moderate Class II Terminated

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

Reported: April 6, 2022 Initiated: March 23, 2022 #D-0737-2022

Product Description

Reason for Recall

Failed Dissolution Specifications; during long term stability testing.

Details

Recalling Firm: Dr. Reddy's Laboratories, Inc.
Units Affected: 8,352 bottles (30-count), 1,368 bottles (90-count)
Distribution: Nationwide in the USA
Location: Princeton, NJ

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 8,352 bottles (30-count), 1,368 bottles (90-count).

Why was this product recalled? ▼

Failed Dissolution Specifications; during long term stability testing.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on April 6, 2022. Severity: Moderate. Recall number: D-0737-2022.