Vancomycin Ophthalmic Solution Recalled Due to Sterility Concerns
Family Pharmacy of Statesville is recalling Vancomycin 14 mg/mL Fortified Ophthalmic Solution due to lack of assurance of sterility. The affected lot was distributed in North Carolina.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a compounded drug product. Lack of sterility assurance in an ophthalmic solution represents a significant infection risk to a sensitive anatomical site (the eye), meeting the Severe classification criterion for Class II recalls with risk of serious harm.
Plain-English summary
Family Pharmacy of Statesville, Inc. is recalling Vancomycin 14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles (Rx only) due to lack of assurance of sterility.
The recalled product includes 3 bottles from Lot 07312020@2 with a beyond-use date (BUD) of 9/14/2020. Distribution was limited to North Carolina.
Non-sterile ophthalmic solutions can pose a risk of eye infection. Patients who have received doses from the affected lot should consult their prescribing physician or healthcare provider about appropriate follow-up care.
The recalling firm, Family Pharmacy of Statesville, has been notified of this action. Consumers who have this product should not use it and should contact their pharmacy or healthcare provider for guidance.
The recalled product
- Product
- Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
- Manufacturer
- Family Pharmacy of Statesville
- Category
- Drug — Ophthalmic / Compounded
- Hazard
- sterility-failure
- infection-risk
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 (1)
- Lot: 07312020@2 BUD: 9/14/2020
Distribution
Distributed in 1 state:
- NC
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