FDA-Drug2022-03-30Class II
Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, 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
30,497 bottles
Manufactured in
105 Lincoln Avenue, N/A, Buena, NJ, United States
Products
Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0692-2022Don't want to check this manually?
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