Home / Recalls / Mylan Pharmaceuticals Inc. / D-0428-2019

D-0428-2019 Class II Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
February 6, 2019
Initiation Date
January 18, 2019
Termination Date
October 9, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
88,090 bottles

Product Description

Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.

Reason for Recall

Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: a) 3085490, 3085491, Exp 04/19; b) 3085492, 3085493, 3085494, 3085495, 3085496, Exp 04/19

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  • D-1057-2020 Class III — Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals I (March 23, 2020)