Recalls / Class III
Class IIID-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.
- Affected lot / code info
- Lot #: 418N, Exp 06/13
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.
Recalling firm
- Firm
- Fougera Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Cantiague Rock Road, Hicksville, New York 11801-1126
Distribution
- Quantity
- 444 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2012-06-07
- FDA classified
- 2012-07-25
- Posted by FDA
- 2012-08-01
- Terminated
- 2015-11-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1426-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.