Why it was recalled
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Product description
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Lot numbers, UPCs & expiration codes
Lot #: H003037, exp. date May 2022; H100132, exp. date June 2022; H100847, exp. date October 2022
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0326-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 22, 2021
- FDA report date
- Jan 12, 2022
- Quantity
- 50,832 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0326-2022, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 89268
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #: H003037, exp. date May 2022; H100132, exp. date June 2022; H100847, exp. date October 2022
- Postal code
- 21202-6174
- Report date
- Jan 12, 2022
- Product type
- Drugs
- Recall number
- D-0326-2022
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 50,832 bottles
- Termination date
- Sep 12, 2022
- Reason for recall
- Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Dec 22, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 4, 2022