Why it was recalled
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Product description
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Lot numbers, UPCs & expiration codes
Lot # 3082876, exp. date January 2020 Lot # 3082877, exp. date January 2020
Where it was sold
Product was distributed to wholesalers, distributors , retail pharmacies, charitable organizations and mail order pharmacies throughout the United States and the product may have been further distributed.
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-0792-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 7, 2020
- FDA report date
- Jan 29, 2020
- Quantity
- 16,944 bottles of 30 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0792-2020, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 84607
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot # 3082876, exp. date January 2020 Lot # 3082877, exp. date January 2020
- Postal code
- 26505-2730
- Report date
- Jan 29, 2020
- Product type
- Drugs
- Recall number
- D-0792-2020
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 16,944 bottles of 30 capsules
- Termination date
- May 19, 2021
- Reason for recall
- CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
- Distribution pattern
- Product was distributed to wholesalers, distributors , retail pharmacies, charitable organizations and mail order pharmacies throughout the United States and the product may have been further distributed.
- Recall initiation date
- Jan 7, 2020
- Initial firm notification
- Letter
- Center classification date
- Jan 20, 2020