Why it was recalled
Presence of precipitate
Product description
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
Lot numbers, UPCs & expiration codes
Lot#: 04092018@2, Exp 12/03/2018
Where it was sold
U.S.A. Nationwide.
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-0239-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 18, 2018
- FDA report date
- Oct 31, 2018
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Promise Pharmacy LLC
Original FDA data
Every field from FDA enforcement report D-0239-2019, exactly as published.
Show all FDA fields
- City
- Palm Harbor
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 81351
- Address
- 31818 US Highway 19 N
- Code information
- Lot#: 04092018@2, Exp 12/03/2018
- Postal code
- 34684-3713
- Report date
- Oct 31, 2018
- Product type
- Drugs
- Recall number
- D-0239-2019
- Classification
- Class III
- Recalling firm
- Promise Pharmacy LLC
- Termination date
- Oct 22, 2020
- Reason for recall
- Presence of precipitate
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
- Distribution pattern
- U.S.A. Nationwide.
- Recall initiation date
- Oct 18, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 8, 2018