Why it was recalled
FAILED DISSOLUTION SPECIFICATIONS
Product description
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856079, NDC 43598-560-78
Lot numbers, UPCs & expiration codes
Lot T2100514, Exp 01/2023
Where it was sold
Nationwide in the USA
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-1287-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 13, 2022
- FDA report date
- Aug 3, 2022
- Quantity
- 2,892 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1287-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90601
- Address
- 107 College Rd E
- Code information
- Lot T2100514, Exp 01/2023
- Postal code
- 08540-6623
- Report date
- Aug 3, 2022
- Product type
- Drugs
- Recall number
- D-1287-2022
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 2,892 cartons
- Termination date
- Dec 6, 2023
- Reason for recall
- FAILED DISSOLUTION SPECIFICATIONS
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856079, NDC 43598-560-78
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 13, 2022
- Initial firm notification
- Letter
- Center classification date
- Jul 22, 2022