Lansoprazole Delayed-Release Capsules recalled over labeling errors

Recall date

September 8, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Mckesson Packaging Services recalls Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx…

Recall number

D-1550-2016

FDA classification

Class III

Brand / firm

Mckesson Packaging Services

Sold / distributed

Nationwide

Why it was recalled

Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only, Manufactured by: Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd Floor 7, Bridgewater, NJ 08807, NDC 63739-0555-10