Lupin Pharmaceuticals Inc.: Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.

Is my product affected?

Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.

• Brand MOXIFLOXACIN

Check against the official notice below — it lists the full affected range.

What happened

Lupin Pharmaceuticals is recalling moxifloxacin ophthalmic solution (an antibiotic eye drop), 0.5%, in 3 mL bottles, due to high levels of impurities that exceed acceptable specifications. This is an expansion of previous recalls from July 2018 and February 2019. Approximately 674,628 bottles were distributed nationwide in the USA and Puerto Rico, with expiration dates ranging from March 2019 through December 2020. The affected bottles have specific lot numbers listed in the recall, such as H701618, H701619, and H701620 among many others.

The record does not specify what consumers should do with their product or what remedy Lupin Pharmaceuticals is offering.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.

Details from the source

Reason for recall: Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities. Distribution: Nationwide in the USA and Puerto Rico. Quantity: 674,628 bottles Lot/code info: Lots: H701618, H701619, H701620, Exp March 2019; H702220, H702221, H702222, H702223, H702224, H702225, H702351, Exp April 2019; H702971, H702972, H702973, H702974, H703151, H703152, H703153, Exp June 2019; H703155, H703682, H703683, Exp July 2019; H704243, H704245, H704247, Exp September 2019; H704707, H704709, H705038, H705039, Exp October 2019; H705561, Exp November 2019; H800394, H800395, H800617, H800618, Exp January 2020; H801585, H801586, H801721, H801722, Exp March 2020; H802138, H802139, H802140, Exp April 2020; H802421, H802707, H802718, Exp May 2020; H803187, H803188, H803232, Exp June 2020; H803749, H803750, Exp July 2020; H804326, H804327, H804328, H804330, H804549, H804552, H804630, H804632, Exp September 2020; H805163, H805361, H805362, H805676, Exp November 2020; H805690, H805692, H805694, Exp December 2020

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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 68180-422-012019-02-01
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All FDA (Drug enforcement) recalls