FDA-Drug2019-02-06Class II
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
Mylan Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Sold states
Nationwide in the USA
Affected count
88,090 bottles
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0428-2019Don't want to check this manually?
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