Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Batch: a) 15342, 15343, 16686, Exp. 3/31/2023; b) 15259, 15260, Exp. 3/31/2022; 15282, Exp. 4/30/2022; 15283, Exp. 5/31/2022; 15725, 15745, 15764, Exp. 6/30/2022; 16066, Exp. 10/31/2022
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Teligent Pharma, Inc.
- Reason for Recall:
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Product Codes/Lot Numbers:
Batch: a) 15342, 15343, 16686, Exp. 3/31/2023; b) 15259, 15260, Exp. 3/31/2022; 15282, Exp. 4/30/2022; 15283, Exp. 5/31/2022; 15725, 15745, 15764, Exp. 6/30/2022; 16066, Exp. 10/31/2022
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0686-2022
Related Recalls
Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.
Teligent Pharma
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.