FDA-Drug2012-08-01Class III

Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0.

Fougera Pharmaceuticals, Inc.
Hazard

Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.

Sold states
Nationwide.
Affected count
444 bottles
Manufactured in
55 Cantiague Rock Road, Hicksville, NY, United States
Products
Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1426-2012

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