FDA-Drug2019-07-31Class II
GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16.
Pharma-Natural Inc.
Hazard
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Sold states
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Affected count
3000 bottles
Manufactured in
14500 Nw 60th Ave Bldg 7f, N/A, Miami Lakes, FL, United States
Products
GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1497-2019Don't want to check this manually?
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