Drug recall D-0484-2019

Class III Terminated reported Feb 20, 2019

Product

Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.

Lots and codes

Lot Numbers: H705562, H705563, EXP. 11/2019; H800616, EXP. 01/2020

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
43,860 3ml bottles
Distribution
Product was distributed by 5 wholesalers, 6 drug chains, 4 mail order pharmacies and 1 mail order pharmacy/supermarket who may have further distribute the product throughout the United States.
Type
Voluntary: Firm initiated
Recall initiated
February 1, 2019
Terminated
June 26, 2020

Related products