Recalls / Class III
Class IIID-0484-2019
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
- Brand name
- Moxifloxacin
- Generic name
- Moxifloxacin
- Active ingredient
- Moxifloxacin Hydrochloride Monohydrate
- Route
- Ophthalmic
- NDC
- 68180-422
- FDA application
- ANDA202867
- Affected lot / code info
- Lot Numbers: H705562, H705563, EXP. 11/2019; H800616, EXP. 01/2020
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.
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
- 43,860 3ml bottles
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2019-02-01
- FDA classified
- 2019-02-08
- Posted by FDA
- 2019-02-20
- Terminated
- 2020-06-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0484-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.