Drug product
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
D-1550-2016
Product summary
- Event
- Event 75141
- Status
- Terminated
- Classification
- Class III
- Quantity
- 181 unit cartons of 10 x 10 blister cards
- Official record key
drug-enforcement:D-1550-2016
Official wording
Reason: 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.
Code information: Lot # 0111295, Exp 9/17
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled