🔍 RecallPedia

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.

Class I - Dangerous
💊 Drugs Recalled: February 26, 2019 Lupin Pharmaceuticals Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Lupin Pharmaceuticals Inc.
Reason for Recall:
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0517-2019

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