Home / Recalls / Mylan Pharmaceuticals Inc. / D-1848-2019

D-1848-2019 Class III Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
September 18, 2019
Initiation Date
September 6, 2019
Termination Date
July 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,157 5 mL bottles

Product Description

Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35

Reason for Recall

Failed Impurities/Degradation Specifications:OOS for unknown impurity.

Distribution Pattern

Nationwide in the USA

Code Information

Lot GABH0003, EXP 7/2020

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