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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

Ethex Corp: The products were not made in conformance with GMP's

Agency Publication Date: May 1, 2009
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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 50826
Status: Resolved
Manufacturer: Ethex Corp
Manufactured In: United States
Units Affected: 148 products (53,522 bottles; 33,678 bottles; 52,771/100 count bottles and 38,512/100 count blister cartons; 39,606/100 count bottles and 10,865/100 count blister cartons; 24,058 bottles; 3,223,182/100 count bottles; 94,358/100 count unit dose cartons; 322,445/500 count bottles; 1,906,953/100 count bottles; 49,155/100 count unit dose cartons; 232,848/500 count bottles; 464,379 bottles; 1,218,915/100 count bottles; 20,568/100 count unit dose cartons; 44,393/1,000 count bottles; 1,484,678/100 count bottles; 23,172/100 count unit dose cartons; 85,770/1,000 count bottles; 2,646,590/100 count bottles; 21,744/100 count unit dose cartons; 182,520/1,000 count bottles; 667,149/100 count bottles and 23,484/1,000 count bottles; 192,005 bottles; 214,981 bottles; 356,066 bottles; 63,204 bottles; 8,424 bottles; 755,161 bottles; 700,584 bottles; 404,620/100 count bottles and 5,135/100 count unit dose cartons; 217,484 bottles; 61,473 bottles; 176,486 bottles; 388,873/100 count bottles and 39,179/500 count bottles; 639,524/100 count bottles and 54,587/500 count bottles; 552,600/100 count bottles and 54,892/500 count bottles; 133,896/100 count bottles; 11,028/100-ct. unit dose ctns, and 6,492/500 count bottles; 110,065 bottles; 122,618 bottles; 159,496 bottles; 45,252/100-ct. btls and 30,477/500-ct. btls.; 79,594/100-ct. btls and 81,026/500-ct. btls; 98,734/100-ct. btls. and 50,444/500-ct. btls.; 22,444 bottles; 70,151/30-ct. btls and 88,824/90-ct. btls; 122,411/30-ct. btls, 136,716/90-ct. btls, and 740/100-ct. unit dose ctns; 184,163/30-ct. btls, 193,440/90-ct. btls, and 697/100-ct. unit dose ctns; 80,944/30-ct. btls. and 71,208/90-ct. btls.; 221,017/30-ct. btls, 262,437/90-ct. btls, and 4,061/100-ct. units dose ctns; 76,720/30-ct. btls and 43,783/90-ct. btls; 173,205 bottles; 124,878/100-ct. btls and 9,496/500-ct. btls; 351,074/100-ct. btls and 33,994/500-ct. btls; 330,755/100-ct. btls and 19,396/500-ct. btls; 298,513 bottles; 223,643/120-ct. btls and 46,300/1,000-ct. btls; 157,440/120-ct. btls. and 36,782/1,000-ct. btls.; 24,144/8-oz. tubes; 16,407/8-oz. tubes; 6,900/1-oz. tubes; 244,163/1-oz. tubes; 15,084/1-oz. tubes; 1,134,702/1-fl. oz. btls. and 9,183/30/1-ml. InveAmp ampoule ctns.; 223,664 bottles; 16,756 bottles; 198,736 bottles; 910,785 bottles; 6,983 bottles; 12,860 bottles; 143,863 bottles; 39,146 bottles; 956,614/16-fl. oz. btls and 31,300/32-fl. oz. btls.; 14,074 bottles; 328,293 bottles; 163,311/1-oz. tubes; 115,404/1-oz. tubes; 50,769/1-oz. tubes; 22,869 bottles; 6,719 bottles; 10,186 bottles; 87,343 bottles; 13,968 bottles; 8,520 bottles; 217,710 bottles; 578,452 bottles; 449,768 bottles; 663,030 bottles; 432,893 bottles; 44,102 bottles; 151,951 bottles; 2,227,535 bottles; 12,067 ampoules; 35,745 ampoules; 161,244 bottles; 3,381,799 bottles; 32,635 bottles; 545,447 bottles; 59,076 bottles; 96,355 bottles; 48,494 boxes; 51,999 boxes; 1,803,807 units; 892,710 units; 63,096 bottles; 516,178 bottles; 21,732 bottles; 525,877 bottles; 204,410 bottles; 148,452 bottles; 386,699 bottles; 75,000 bottles; 80,868 bottles; 10,985 bottles; 6,948 bottles; 47,258 bottles; 8,892 bottles; 5677 bottles; 362,612 bottles; 7386 bottles; 283,323 - 100 tablet bottles and 25,313 - 500 count bottles; 22,806 bottles; 2,155,830 units; 108,000 units; 808,683 bottles; 118,576 bottles; 72,414 bottles; 454,429 bottles; 25,271 bottles; 50,724 bottles; 14,810 bottles; 63,127 bottles; 13,990 bottles; 108,168 bottles; 33,989 bottles; 11,376 bottles; 5,856 bottles; 57,613 bottles; 86,553 boxes; 33,852 bottles; 13,476 bottles; 95,158 bottles; 7,764 bottles; 16,188 bottles; 75,696 bottles; 18,680 bottles; 14,305 bottles; 875,108 bottles; 18,379 bottles; 24,607 bottles; 57,914 bottles; 108,618 bottles; 89,196 bottles; 23,714 bottles; 104,533 bottles; 112,718 bottles; 458,131 bottles and 81,408 packs; 36,184 bottles; 83,996 bottles)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.