Reported Aug 1, 2012 · Terminated
Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera…
Fougera Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fougera Pharmaceuticals, Inc. · 55 Cantiague Rock Road · Hicksville, NY · 11801-1126
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: 418NExp 06/13
- Amount recalled
- 444 bottles
Where it was sold
- Nationwide
Why it was recalled
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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