Why it was recalled
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 31804, Exp 11/2019; 31911, 31917, Exp 02/2020; 32067, 32072, 32084, Exp 06/2020; 32248, Exp 10/2020
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-1058-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 18, 2019
- FDA report date
- Apr 3, 2019
- Quantity
- 29,435 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ingenus Pharmaceuticals Llc
Original FDA data
Every field from FDA enforcement report D-1058-2019, exactly as published.
Show all FDA fields
- City
- Orlando
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 82401
- Address
- 4190 Millenia Blvd
- Code information
- Lot #: 31804, Exp 11/2019; 31911, 31917, Exp 02/2020; 32067, 32072, 32084, Exp 06/2020; 32248, Exp 10/2020
- Postal code
- 32839-6408
- Report date
- Apr 3, 2019
- Product type
- Drugs
- Recall number
- D-1058-2019
- Classification
- Class III
- Recalling firm
- Ingenus Pharmaceuticals Llc
- Product quantity
- 29,435 bottles
- Termination date
- Mar 6, 2020
- Reason for recall
- Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Mar 18, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 25, 2019