FDA-Drug2017-02-01Class II

Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.

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
588 bottles
Manufactured in
Road #156, Km. 58.8, Lot 24B, N/A, Caguas, PR, United States
Products
Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0444-2017

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