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
Check against the official notice below — it lists the full affected range.
Lupin Pharmaceuticals Inc. is recalling Moxifloxacin Ophthalmic Solution USP, 0.5%, a prescription eye drop medication sold in 3 mL dropper bottles. The recall affects approximately 43,860 bottles with lot numbers H705562, H705563 (expiring 11/2019), and H800616 (expiring 01/2020). The product was distributed nationwide through five wholesalers, six drug chains, and two mail order pharmacies.
The recall was initiated because testing revealed that impurities and degradation substances in the medication exceeded acceptable specifications during a three-month stability study. The recall record does not specify what consumers or patients should do regarding this product.
Written by software from the official notice below. Not reviewed by a lawyer.
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Reason for recall: Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained. 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. Quantity: 43,860 3ml bottles Lot/code info: Lot Numbers: H705562, H705563, EXP. 11/2019; H800616, EXP. 01/2020
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.