Recalls / Class III
Class IIID-1050-2018
Product
Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, 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
- Lot #: H800393, Exp. 01/2020
Why it was recalled
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 13,896 bottles
- Distribution pattern
- Product was distributed throughout the United States
Timeline
- Recall initiated
- 2018-07-26
- FDA classified
- 2018-08-08
- Posted by FDA
- 2018-08-08
- Terminated
- 2019-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1050-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.