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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

Profarma Distributors LLC: CGMP Deviations

Agency Publication Date: June 17, 2016
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Affected Products

Product: tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057

Lot # 224TS; Exp. 02/17

Lot Numbers:
224TS
Product: tabcin NOCHE; Capsules,12-count box, UPC 501008485033

Lot # X223FS; Exp. 11/17

Lot Numbers:
X223FS
Product: VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619

Lot # UPE187; Exp. 08/17

Lot Numbers:
UPE187
Product: VERMOX Tablets 500 mg, 1-count box, UPC 501109900596

Lot # UJE 040; Exp. 02/17

Lot Numbers:
UJE
Product: 1% Clotrimazol cream, 30 mg tube, UPC 501318644335

Lot # GRU1390; Exp. 08/17

Lot Numbers:
GRU1390

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 74135
Status: Resolved
Manufacturer: Profarma Distributors LLC
Manufactured In: United States
Units Affected: 5 products (42 boxes (504 capsules); 31 boxes ( 372 capsules); 163 boxes (978 tablets); 254 boxes (254 tablets); 79 boxes (79 tubes))

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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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.