Why it was recalled
Failed Dissolution Specifications; during long term stability testing.
Product description
Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India
Lot numbers, UPCs & expiration codes
Lot # a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023.
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-0737-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 23, 2022
- FDA report date
- Apr 6, 2022
- Quantity
- 8,352 bottles (30-count), 1,368 bottles (90-count)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0737-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89871
- Address
- 107 College Rd E
- Code information
- Lot # a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023.
- Postal code
- 08540-6623
- Report date
- Apr 6, 2022
- Product type
- Drugs
- Recall number
- D-0737-2022
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 8,352 bottles (30-count), 1,368 bottles (90-count)
- Termination date
- Feb 2, 2024
- Reason for recall
- Failed Dissolution Specifications; during long term stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 23, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 31, 2022