Why it was recalled
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Product description
Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
Lot numbers, UPCs & expiration codes
Lot 2CT0486 , Exp 02/29/2024
Where it was sold
Nationwide in the USA
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-1497-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 17, 2022
- FDA report date
- Sep 7, 2022
- Quantity
- 57,816 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Padagis US LLC
Original FDA data
Every field from FDA enforcement report D-1497-2022, exactly as published.
Show all FDA fields
- City
- Minneapolis
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 90790
- Address
- 3940 Quebec Ave N
- Code information
- Lot 2CT0486 , Exp 02/29/2024
- Postal code
- 55427-1244
- Report date
- Sep 7, 2022
- Product type
- Drugs
- Recall number
- D-1497-2022
- Classification
- Class II
- Recalling firm
- Padagis US LLC
- Product quantity
- 57,816 tubes
- Termination date
- Sep 28, 2023
- Reason for recall
- CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 17, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 7, 2022