FDA Recalls Neomycin Ophthalmic Ointment Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Neomycin + Polymyxin B + Bacitracin Ophthalmic Ointment because FDA inspections found GMP violations that may affect sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of serious injury or infection.
Plain-English summary
The Compounding Pharmacy of America is recalling Neomycin + Polymyxin B + Bacitracin Ophthalmic Ointment. The recall was initiated after FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is a 200 gm ophthalmic ointment distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, specifically lot numbers 01282015@15 and 03182015@54.
Consumers should stop using the product and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment, grams, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Ophthalmic Ointment
- Hazard
- Affected units
- 200
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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