Reported Mar 6, 2019 · Terminated
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454…
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 bottle, Rx only
- Manufactured byLupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01
- Lot codes and dates
16 of 16 products
Products covered by this recall # Product as published 1 H701618, H701619, H701620, Exp March 2019 2 H702220, H702221, H702222, H702223, H702224, H702225, H702351, Exp April 2019 3 H702971, H702972, H702973, H702974, H703151, H703152, H703153, Exp June 2019 4 H703155, H703682, H703683, Exp July 2019 5 H704243, H704245, H704247, Exp September 2019 6 H704707, H704709, H705038, H705039, Exp October 2019 7 H705561, Exp November 2019 8 H800394, H800395, H800617, H800618, Exp January 2020 9 H801585, H801586, H801721, H801722, Exp March 2020 10 H802138, H802139, H802140, Exp April 2020 11 H802421, H802707, H802718, Exp May 2020 12 H803187, H803188, H803232, Exp June 2020 13 H803749, H803750, Exp July 2020 14 H804326, H804327, H804328, H804330, H804549, H804552, H804630, H804632, Exp September 2020 15 H805163, H805361, H805362, H805676, Exp November 2020 16 H805690, H805692, H805694, Exp December 2020 - Amount recalled
- 674,628 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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