Recalls / Class III
Class IIID-0517-2019
Product
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.
- Brand name
- Moxifloxacin
- Generic name
- Moxifloxacin
- Active ingredient
- Moxifloxacin Hydrochloride Monohydrate
- Route
- Ophthalmic
- NDC
- 68180-422
- FDA application
- ANDA202867
- Affected lot / code info
- Lots: H701618, H701619, H701620, Exp March 2019; H702220, H702221, H702222, H702223, H702224, H702225, H702351, Exp April 2019; H702971, H702972, H702973, H702974, H703151, H703152, H703153, Exp June 2019; H703155, H703682, H703683, Exp July 2019; H704243, H704245, H704247, Exp September 2019; H704707, H704709, H705038, H705039, Exp October 2019; H705561, Exp November 2019; H800394, H800395, H800617, H800618, Exp January 2020; H801585, H801586, H801721, H801722, Exp March 2020; H802138, H802139, H802140, Exp April 2020; H802421, H802707, H802718, Exp May 2020; H803187, H803188, H803232, Exp June 2020; H803749, H803750, Exp July 2020; H804326, H804327, H804328, H804330, H804549, H804552, H804630, H804632, Exp September 2020; H805163, H805361, H805362, H805676, Exp November 2020; H805690, H805692, H805694, Exp December 2020
Why it was recalled
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 674,628 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2019-02-26
- FDA classified
- 2019-02-28
- Posted by FDA
- 2019-03-06
- Terminated
- 2020-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0517-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.