FDA-Drug2016-10-05Class III

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

Mckesson Packaging Services
Hazard

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.

Sold states
Nationwide
Affected count
181 unit cartons of 10 x 10 blister cards
Manufactured in
7101 Weddington Rd NW, N/A, Concord, NC, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1550-2016

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