Why it was recalled
Failed Dissolution Specifications
Product description
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.
Lot numbers, UPCs & expiration codes
Lot #: T2000645, Exp 07/2022
Where it was sold
OH
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-0853-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 15, 2022
- FDA report date
- May 11, 2022
- Quantity
- 252 Blister Packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0853-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90021
- Address
- 107 College Rd E
- Code information
- Lot #: T2000645, Exp 07/2022
- Postal code
- 08540-6623
- Report date
- May 11, 2022
- Product type
- Drugs
- Recall number
- D-0853-2022
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 252 Blister Packs
- Termination date
- Nov 7, 2023
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.
- Distribution pattern
- OH
- Recall initiation date
- Apr 15, 2022
- Initial firm notification
- Letter
- Center classification date
- May 5, 2022