Drug 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.
D-1426-2012
Product summary
- Event
- Event 62136
- Status
- Terminated
- Classification
- Class III
- Quantity
- 444 bottles
- Official record key
drug-enforcement:D-1426-2012
Official wording
Reason: Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Code information: Lot #: 418N, Exp 06/13
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination