Why it was recalled
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Product description
Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35
Lot numbers, UPCs & expiration codes
Lot GABH0003, EXP 7/2020
Where it was sold
Nationwide in the USA
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-1848-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 6, 2019
- FDA report date
- Sep 18, 2019
- Quantity
- 13,157 5 mL bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1848-2019, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 83673
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot GABH0003, EXP 7/2020
- Postal code
- 26505-2730
- Report date
- Sep 18, 2019
- Product type
- Drugs
- Recall number
- D-1848-2019
- Classification
- Class III
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 13,157 5 mL bottles
- Termination date
- Jul 16, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications:OOS for unknown impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Sep 9, 2019