FDA-Drug2017-02-01Class II
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), 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) 300 bottles (lot 2006915); b) 156 bottles (lot 2006914)
Manufactured in
Road #156, Km. 58.8, Lot 24B, N/A, Caguas, PR, United States
Products
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0443-2017Don't want to check this manually?
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