Why it was recalled
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Product description
Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
Lot numbers, UPCs & expiration codes
Lot # 3063759, Exp.07/16
Where it was sold
Nationwide
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-0650-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 28, 2016
- FDA report date
- Feb 10, 2016
- Quantity
- 868 unit cartons (86,800 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Original FDA data
Every field from FDA enforcement report D-0650-2016, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 73170
- Address
- 1718 Northrock Ct
- Code information
- Lot # 3063759, Exp.07/16
- Postal code
- 61103-1201
- Report date
- Feb 10, 2016
- Product type
- Drugs
- Recall number
- D-0650-2016
- Classification
- Class III
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Product quantity
- 868 unit cartons (86,800 tablets)
- Termination date
- Dec 21, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 28, 2016
- Initial firm notification
- Letter
- Center classification date
- Feb 2, 2016