Why it was recalled
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Product description
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Lot numbers, UPCs & expiration codes
LOT #: a) 2006895 and 2006896, Exp 02/18; b) 2006895, Exp 02/18
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-0441-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 20, 2016
- FDA report date
- Feb 1, 2017
- Quantity
- a) 574 bottles (lot 2006895) and 495 bottles (lot 2006896); b) 744 bottles (lot 2006895)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan LLC.
Original FDA data
Every field from FDA enforcement report D-0441-2017, exactly as published.
Show all FDA fields
- City
- Caguas
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 76020
- Address
- Road #156, Km. 58.8, Lot 24B
- Code information
- LOT #: a) 2006895 and 2006896, Exp 02/18; b) 2006895, Exp 02/18
- Postal code
- 00725
- Report date
- Feb 1, 2017
- Product type
- Drugs
- Recall number
- D-0441-2017
- Classification
- Class II
- Recalling firm
- Mylan LLC.
- Product quantity
- a) 574 bottles (lot 2006895) and 495 bottles (lot 2006896); b) 744 bottles (lot 2006895)
- Termination date
- Jan 25, 2018
- Reason for recall
- Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 20, 2016
- Center classification date
- Jan 25, 2017