Why it was recalled
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Product description
Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
Lot numbers, UPCs & expiration codes
Lot #348716 (exp. 12/2017)
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-0152-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 14, 2016
- FDA report date
- Nov 30, 2016
- Quantity
- a) 62 tubes and b) 91 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn Inc
Original FDA data
Every field from FDA enforcement report D-0152-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 75628
- Address
- 1925 W Field Ct
- Code information
- Lot #348716 (exp. 12/2017)
- Postal code
- 60045-4862
- Report date
- Nov 30, 2016
- Product type
- Drugs
- Recall number
- D-0152-2017
- Classification
- Class II
- Recalling firm
- Akorn Inc
- Product quantity
- a) 62 tubes and b) 91 tubes
- Termination date
- May 10, 2019
- Reason for recall
- Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 14, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 23, 2016