Is Pro-Mex ***Ampitrexyl Suspension***PARA NINOS ***4 oz (120 mL)*** DIETARY SUPPLEMENT***Propiedades Anitibotico Natural***Sabor a Cereza***Ingredients: Andrographitis Extract 450 mg * Corydails Yanhusuo 4: 150 mg * Burdock Root * Garlic extract * Spleen * Echineacea Extract * Flavor ***". recalled?

Medium RiskFDA Drug

Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals: CGMP Deviations; products were not manufactured under cGMP's and not stored in controlled temperature and humidity conditions.

Agency Publication Date: September 12, 2011

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 59145

Status: Resolved

Manufacturer: Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals

Manufactured In: United States

Units Affected: 64 products (10,250 bottles; 9,520 bottles; 356 bottles; 228 bottles; 1,135 bottles; 3,718 bottles; 14 boxes; 4,967 boxes; 4,827 boxes; 4,693 boxes; 6 boxes; 19,297 boxes; 24,191 boxes; 2,266 boxes; 35,709 tubes; 49,427 tubes; 5 tubes; 1,560 boxes; 27,089 bottles; 21 bottles; 6 bottles; 1,896 bottles; 948 boxes; 3,458 boxes; 5,893 tubes; 998 boxes; 168 tubes; 1,265 boxes; 16,744 tubes; 24,312 boxes; 1,883 bottles; 1,957 bottles; 1,516 bottles; 201 bottles; 225,412 bottles; 4,046 tubes; 35,887 bottles; 2,016 bottles; 72 bottles; 3,763 bottles; 5,186 bottles; 5,174 bottles; 4,579 tubes; 3,730 bottles; 1,591 tubes; 7,229 bottles; 8,474 tubes; 35,503 boxes; Unknown; 3,079 btls; 533 btls; 6 btls; 22 btls; 42 btls; 1, 224 boxes; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown)

Were You Affected by This Recall?

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Sources: FDA iRES · Raw API Response

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