Status
Terminated
Drug Enforcement D-1426-2012
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Classification
Class III
Report Date
August 1, 2012
Termination Date
November 30, 2015
Product Information
- 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.
- Product quantity
- 444 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- Fougera Pharmaceuticals, Inc.
- Address
-
55 Cantiague Rock Road
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1426-2012
- Event ID
- 62136
- Recall initiation date
- June 7, 2012
- Center classification date
- July 25, 2012
- Code info
- Lot #: 418N, Exp 06/13
- More code info
- —