FDA Drug Class II — Moderate

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

Hazard

Failed Dissolution Specifications; during long term stability testing.

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Products

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 -
Brand
Dr. Reddy's Laboratories, Inc.
UPC
Lot # a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023.

Units Affected

8,352 bottles (30-count), 1,368 bottles (90-count)

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