FDAFDA · Food and drugs·Recall number D-1050-2018
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
Published August 8, 2018 · Recall initiated: July 26, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MOXIFLOXACIN
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Product was distributed throughout the United States
- UPC
- 0368180422013
- Lot
- Lot #: H800393, Exp. 01/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.