Why it was recalled
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Product description
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
Lot numbers, UPCs & expiration codes
a) 357052, exp 4/19/19 b) 356892, exp 4/16/19 and 356927, exp 4/15/19
Where it was sold
Nationwide, including 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-0515-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 25, 2019
- FDA report date
- Feb 27, 2019
- Quantity
- a) 4896 tubes; b) 5064 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn Inc
Original FDA data
Every field from FDA enforcement report D-0515-2019, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 82092
- Address
- 1925 W Field Ct Ste 300
- Code information
- a) 357052, exp 4/19/19 b) 356892, exp 4/16/19 and 356927, exp 4/15/19
- Postal code
- 60045-4862
- Report date
- Feb 27, 2019
- Product type
- Drugs
- Recall number
- D-0515-2019
- Classification
- Class III
- Recalling firm
- Akorn Inc
- Product quantity
- a) 4896 tubes; b) 5064 tubes
- Termination date
- Nov 3, 2020
- Reason for recall
- Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
- Distribution pattern
- Nationwide, including Puerto Rico.
- Recall initiation date
- Jan 25, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 20, 2019