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
Reported: August 8, 2018 Initiated: July 26, 2018 #D-1050-2018
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 13,896 bottles
- Distribution
- Product was distributed throughout the United States
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 13,896 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 8, 2018. Severity: Low. Recall number: D-1050-2018.
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