FDA recall D-1426-2012

Product

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.

Reason for recall

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

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2012-06-07

Report date

2012-08-01

Termination date

2015-11-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hicksville, NY, United States

Primary source

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