Home / Recalls / Mylan LLC. / D-066-2013

D-066-2013 Class II Terminated

Recalled by Mylan LLC. — Caguas, PR

Recall Details

Product Type
Drugs
Report Date
December 5, 2012
Initiation Date
June 29, 2012
Termination Date
April 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15181 bottles.

Product Description

Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01

Reason for Recall

Failed USP Content Uniformity Requirements: OOS result reported on retained samples.

Distribution Pattern

Natiowide

Code Information

Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12

Other recalls by Mylan LLC.

  • D-0441-2017 Class II — Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98) (December 20, 2016)
  • 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)