Is RectaGel HC, Topical Gel, Lidocaine HCl 2.8%; Hydrocortisone Acetate 0.55% Gel, Net Weight 20 g, Manufactured by: Deltex Pharmaceuticals Inc, 1700 Bamore Road, Rosenberg, TX 77471 NDC 66663-357-05 recalled?

Medium RiskFDA Drug

Deltex Pharmaceuticals, Inc: CGMP Deviations: Firm failed to comply with current good manufacturing practice requirements.

Agency Publication Date: May 4, 2011

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 58065

Status: Resolved

Manufacturer: Deltex Pharmaceuticals, Inc

Manufactured In: United States

Units Affected: 37 products (20,884 tubes; 7,957 bottles; 226,368 bottles; 11,897 bottles; 88,040 bottles; 1,408 bottles; 1,738 bottles; 2,954 bottles; 2,012 bottles; 87,292 bottles; 12,047 bottles; 22,784 bottles; 1,148 bottles; 6,677 bottles; 7,487 bottles; 15,739 bottles; 8,028 bottles; 7,117 bottles; 3,989 bottles; 3,346 bottles; 46,395 bottles; 4,009 bottles; 12,860 bottles; 17,631 bottles; 31,453 bottles; 7,466 bottles; 3,555 bottles; 8,548 bottles; 12,930 bottles; 1,488 bottles; 16,890 bottles; 13,314 bottles; 7,536 bottles; 7,488 bottles; 6,024 bottles; 11,916 bottles; 21,816 bottles)

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.