Recalls / Class III
Class IIID-1550-2016
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
- Affected lot / code info
- Lot # 0111295, Exp 9/17
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.
Recalling firm
- Firm
- Mckesson Packaging Services
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 7101 Weddington Rd NW, N/A, Concord, North Carolina 28027-3412
Distribution
- Quantity
- 181 unit cartons of 10 x 10 blister cards
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-09-08
- FDA classified
- 2016-09-28
- Posted by FDA
- 2016-10-05
- Terminated
- 2017-05-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1550-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.