Reported Feb 20, 2019 · Terminated
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc.…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174
Is this the product you have?
- Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only
- Manufactured forLupin Pharmaceuticals, Inc. Baltimore
- Maryland 21202 Manufactured bylupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01
- Lot codes and dates
- Lot Numbers
H705562H705563EXP. 11/2019H800616EXP. 01/2020
- Lot Numbers
- Amount recalled
- 43,860 3ml bottles
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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