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.
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
Lot numbers, UPCs & expiration codes
Lot # 0111295, Exp 9/17
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1550-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 8, 2016
- FDA report date
- Oct 5, 2016
- Quantity
- 181 unit cartons of 10 x 10 blister cards
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson Packaging Services
Original FDA data
Every field from FDA enforcement report D-1550-2016, exactly as published.
Show all FDA fields
- City
- Concord
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 75141
- Address
- 7101 Weddington Rd NW
- Code information
- Lot # 0111295, Exp 9/17
- Postal code
- 28027-3412
- Report date
- Oct 5, 2016
- Product type
- Drugs
- Recall number
- D-1550-2016
- Classification
- Class III
- Recalling firm
- Mckesson Packaging Services
- Product quantity
- 181 unit cartons of 10 x 10 blister cards
- Termination date
- May 3, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 8, 2016
- Initial firm notification
- Center classification date
- Sep 28, 2016