FDA-Drug2022-03-30Class II
Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
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
6431 bottles
Manufactured in
105 Lincoln Avenue, N/A, Buena, NJ, United States
Products
Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0690-2022Don't want to check this manually?
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