Why it was recalled
Failed Dissolution Specification
Product description
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77
Lot numbers, UPCs & expiration codes
Lot # M005681, EXP 3/2022
Where it was sold
Distributed 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-0074-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 27, 2020
- FDA report date
- Nov 11, 2020
- Quantity
- 6,840 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0074-2021, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86663
- Address
- 73 Route 31 N
- Code information
- Lot # M005681, EXP 3/2022
- Postal code
- 08534-3601
- Report date
- Nov 11, 2020
- Product type
- Drugs
- Recall number
- D-0074-2021
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 6,840 units
- Termination date
- Dec 20, 2022
- Reason for recall
- Failed Dissolution Specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Oct 27, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 10, 2020