Recalls / Class III
Class IIID-0239-2019
Product
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
- Affected lot / code info
- Lot#: 04092018@2, Exp 12/03/2018
Why it was recalled
Presence of precipitate
Recalling firm
- Firm
- Promise Pharmacy LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 31818 US Highway 19 N, N/A, Palm Harbor, Florida 34684-3713
Distribution
- Quantity
- N/A
- Distribution pattern
- U.S.A. Nationwide.
Timeline
- Recall initiated
- 2018-10-18
- FDA classified
- 2018-11-08
- Posted by FDA
- 2018-10-31
- Terminated
- 2020-10-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0239-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.