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.
Reported: August 1, 2012 Initiated: June 7, 2012 #D-1426-2012
Product Description
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.
Details
- Recalling Firm
- Fougera Pharmaceuticals, Inc.
- Units Affected
- 444 bottles
- Distribution
- Nationwide.
- Location
- Hicksville, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fougera Pharmaceuticals, Inc.. Units affected: 444 bottles.
Why was this product recalled? ▼
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 1, 2012. Severity: Low. Recall number: D-1426-2012.
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