Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Product description
Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.
Lot numbers, UPCs & expiration codes
Lot# 2062900, Exp 05/18
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-0617-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 9, 2018
- FDA report date
- Mar 28, 2018
- Quantity
- 4,128 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0617-2018, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 79466
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot# 2062900, Exp 05/18
- Postal code
- 60045-4862
- Report date
- Mar 28, 2018
- Product type
- Drugs
- Recall number
- D-0617-2018
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 4,128 bottles
- Termination date
- Aug 31, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Mar 9, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 3, 2018