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
Reported: February 20, 2019 Initiated: February 1, 2019 #D-0484-2019
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 43,860 3ml bottles
- Distribution
- 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.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 43,860 3ml bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 20, 2019. Severity: Low. Recall number: D-0484-2019.
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