Mylan LLC.: Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

Agency Publication Date: January 25, 2017

Affected Products

Product: 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 #: a) 2006895 and 2006896, Exp 02/18; b) 2006895, Exp 02/18

Product: Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.

LOT #: a) 2006903, Exp 02/18; b) 2006902, Exp 02/18

Product: 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.

LOT #: a) 2006915, Exp 02/18; b) 2006914, Exp 02/18

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

LOT #: 2006912, Exp 02/18

Lot Numbers:

2006912

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76020

Status: Resolved

Manufacturer: Mylan LLC.

Manufactured In: United States

Units Affected: 4 products (a) 574 bottles (lot 2006895) and 495 bottles (lot 2006896); b) 744 bottles (lot 2006895); a) 746 bottles (lot 2006903); b)588 bottles (lot 2006902); a) 300 bottles (lot 2006915); b) 156 bottles (lot 2006914); 588 bottles)

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Sources: FDA iRES · Raw API Response

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