Is Dextroamphetamine Sulfate Tablets, USP, CII, 10 mg, packaged in 100 tablet bottles, 12 bottles/case, Rx only, NDC 58177-312-04, Manufactured by KV Pharmaceutical Co. for ETHEX Corporation, St. Louis, MO recalled?

The products may contain oversized tablets. Distribution: The products were distributed nationwide to wholesale drug distributors. There were no foreign/military/government accounts.

Critical RiskFDA Drug

Ethex Corp: The products may contain oversized tablets.

Agency Publication Date: June 26, 2009

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 50152

Status: Resolved

Manufacturer: Ethex Corp

Manufactured In: United States

Units Affected: 35 products (27,174 bottles; 362,744 bottles; 212,452 bottles; 121,999 bottles; 306,096 bottles; 340,696 bottles; 252,246 bottles or unit dose boxes; 161,624 bottles; 45,093 bottles; 49,365 bottles; 93,456 bottles; 112,977 bottles; 11,964 bottles; 89,557 bottles; 241,983 bottles; 429,735 bottles; 303,558 bottles; 97,967 bottles; 213,345 bottles; 136,621 bottles; 35,355 bottles; 597,795 bottles; 308,250 bottles; 174,847 tablet bottles; 463,989 tablet bottles; 161,851 bottles; 30,958 bottles; 54,153 bottles; 24,976 bottles; 32,532 bottles; 3,624 bottles; 103,322 bottles; 9,683/100-tab. btls.; 58,589 bottles; 19,728 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

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