FDA-Drug2022-03-30Class II
Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Teligent Pharma, Inc.
Hazard
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
43,956 tubes
Manufactured in
105 Lincoln Avenue, N/A, Buena, NJ, United States
Products
Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0687-2022Don't want to check this manually?
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