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, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.
Lot numbers, UPCs & expiration codes
Lot: 12JY2216, Exp. 2/29/24
Where it was sold
Physicians and Medical Facilities in GA and ID
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-1535-2022
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Sep 12, 2022
- FDA report date
- Sep 21, 2022
- Quantity
- 20 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Direct Rx
Original FDA data
Every field from FDA enforcement report D-1535-2022, exactly as published.
Show all FDA fields
- City
- Dawsonville
- State
- GA
- Status
- Completed
- Country
- United States
- Event ID
- 90869
- Address
- 94 Worldwide Dr
- Code information
- Lot: 12JY2216, Exp. 2/29/24
- Postal code
- 30534-6828
- Report date
- Sep 21, 2022
- Product type
- Drugs
- Recall number
- D-1535-2022
- Classification
- Class II
- Recalling firm
- Direct Rx
- Product quantity
- 20 tubes
- 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, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.
- Distribution pattern
- Physicians and Medical Facilities in GA and ID
- Recall initiation date
- Sep 12, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2022