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.
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.
Lot numbers, UPCs & expiration codes
Lot #: 418N, Exp 06/13
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1426-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 7, 2012
- FDA report date
- Aug 1, 2012
- Quantity
- 444 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fougera Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1426-2012, exactly as published.
Show all FDA fields
- City
- Hicksville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 62136
- Address
- 55 Cantiague Rock Road
- Code information
- Lot #: 418N, Exp 06/13
- Postal code
- 11801-1126
- Report date
- Aug 1, 2012
- Product type
- Drugs
- Recall number
- D-1426-2012
- Classification
- Class III
- Recalling firm
- Fougera Pharmaceuticals, Inc.
- Product quantity
- 444 bottles
- Termination date
- Nov 30, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jun 7, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 25, 2012