Why it was recalled
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Product description
Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
Lot numbers, UPCs & expiration codes
Lot#: 1967800, Exp10/2016
Where it was sold
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-1469-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 27, 2016
- FDA report date
- Aug 31, 2016
- Quantity
- 4,045 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1469-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 74794
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot#: 1967800, Exp10/2016
- Postal code
- 60045-4862
- Report date
- Aug 31, 2016
- Product type
- Drugs
- Recall number
- D-1469-2016
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 4,045 units
- Termination date
- Jul 21, 2017
- Reason for recall
- Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 27, 2016
- Initial firm notification
- Letter
- Center classification date
- Aug 24, 2016