Sheffield Triple Antibiotic Ointment Recalled for Stability Failures
Faria Limited LLC is recalling Dr. Sheffield's Triple Antibiotic Ointment because it failed stability specifications and could not meet shelf-life requirements.
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 as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a failure to meet stability specifications rather than a direct safety hazard like contamination or injury.
Plain-English summary
Faria Limited LLC dba Sheffield Pharmaceuticals is recalling 105,744 tubes of Dr. Sheffield's Triple Antibiotic Ointment. The product contains Bacitracin 400 units, Neomycin Sulfate 3.5mg, and Polymyxin-B Sulfate 5,000 units in 0.33oz (9g) tubes.
The recall was initiated because the product failed stability specifications and was unable to meet shelf-life expiry requirements. The affected lots are # 10301 and # 10302, both with an expiration date of 05/14.
The recalled product was distributed in Pennsylvania, Georgia, Washington, and California. Consumers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be discarded or returned to the point of purchase.
The recalled product
- Product
- Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g)
- Manufacturer
- Faria Limited LLC dba Sheffield Pharmaceuticals
- Category
- Drug — Topical Antibiotic
- Hazard
- Affected units
- 105,744
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 (3)
- Lot # 10301
- Exp 05/14 Lot # 10302
- Exp 05/14
Distribution
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