Home / Recalls / Mylan LLC. / D-0441-2017

D-0441-2017 Class II Terminated

Recalled by Mylan LLC. — Caguas, PR

Recall Details

Product Type
Drugs
Report Date
February 1, 2017
Initiation Date
December 20, 2016
Termination Date
January 25, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 574 bottles (lot 2006895) and 495 bottles (lot 2006896); b) 744 bottles (lot 2006895)

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

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

Other recalls by Mylan LLC.

  • D-0444-2017 Class II — Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, (December 20, 2016)
  • D-0443-2017 Class II — Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98) (December 20, 2016)
  • D-0442-2017 Class II — Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98) (December 20, 2016)
  • D-066-2013 Class II — Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceutic (June 29, 2012)