FDA-Drug2017-02-01Class II
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.
Mylan LLC.
Hazard
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Sold states
Nationwide in the USA
Affected count
a) 574 bottles (lot 2006895) and 495 bottles (lot 2006896); b) 744 bottles (lot 2006895)
Manufactured in
Road #156, Km. 58.8, Lot 24B, N/A, Caguas, PR, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0441-2017Don't want to check this manually?
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