Why it was recalled
GMP Deviations; product may not meet cGMP requirements
Product description
Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40
Lot numbers, UPCs & expiration codes
Product Code GEN-23240
Where it was sold
Nationwide 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-0866-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 19, 2017
- FDA report date
- May 31, 2017
- Quantity
- 65 gallons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Gentell, Inc
Original FDA data
Every field from FDA enforcement report D-0866-2017, exactly as published.
Show all FDA fields
- City
- Bristol
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 77196
- Address
- 2701 Bartram Rd
- Code information
- Product Code GEN-23240
- Postal code
- 19007-6810
- Report date
- May 31, 2017
- Product type
- Drugs
- Recall number
- D-0866-2017
- Classification
- Class II
- Recalling firm
- Gentell, Inc
- Product quantity
- 65 gallons
- Termination date
- Feb 16, 2018
- Reason for recall
- GMP Deviations; product may not meet cGMP requirements
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 19, 2017
- Initial firm notification
- Letter
- Center classification date
- May 24, 2017