FDAFDA · Food and drugs·Recall number D-0686-2022
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.
Published March 30, 2022 · Recall initiated: March 15, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teligent Pharma, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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