Fougera Recalls Erythromycin Topical Solution Due to Plasticizer Contamination
Fougera Pharmaceuticals is recalling 444 bottles of Erythromycin Topical Solution USP, 2%, due to potential trace contamination with Di-Octyl Phthalate.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which indicates that use of the product is not likely to cause adverse health consequences. The hazard involves trace amounts of a chemical contaminant without reported injuries.
Plain-English summary
Fougera Pharmaceuticals, Inc. is recalling 444 bottles of Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator. The product is prescription-only and was distributed nationwide. The specific lot number is 418N with an expiration date of 06/13.
The recall was initiated because trace amounts of a plasticizer, identified as Di-Octyl Phthalate, may be present in the product. This constitutes a chemical contamination issue.
Consumers and healthcare providers should check their inventory for this specific product, lot number, and expiration date. If the product is found, it should be returned to the pharmacy or point of purchase for disposal or replacement in accordance with the recalling firm's instructions.
The recalled product
- 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.
- Manufacturer
- Fougera Pharmaceuticals, Inc.
- Category
- Drug — Topical Antibiotic
- Hazard
- Affected units
- 444
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 418N
- Exp 06/13
Distribution
Distributed nationwide across the United States.
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