Recalls / Class III
Class IIID-1058-2019
Product
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
- Affected lot / code info
- Lot #: 31804, Exp 11/2019; 31911, 31917, Exp 02/2020; 32067, 32072, 32084, Exp 06/2020; 32248, Exp 10/2020
Why it was recalled
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Recalling firm
- Firm
- Ingenus Pharmaceuticals Llc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4190 Millenia Blvd, N/A, Orlando, Florida 32839-6408
Distribution
- Quantity
- 29,435 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2019-03-18
- FDA classified
- 2019-03-25
- Posted by FDA
- 2019-04-03
- Terminated
- 2020-03-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1058-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.