FDAFDA · Food and drugs·Recall number D-1426-2012
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.
Published August 1, 2012 · Recall initiated: June 7, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fougera Pharmaceuticals, Inc.
- Distributor
- Nationwide.
- Lot
- Lot #: 418N, Exp 06/13
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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