D-1550-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 5, 2016
- Initiation Date
- September 8, 2016
- Termination Date
- May 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 181 unit cartons of 10 x 10 blister cards
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
Lot # 0111295, Exp 9/17