Liberty Drug Recalls Vancomycin Ophthalmic Solution Due to Sterility Concerns
Liberty Drug & Surgical is recalling Vancomycin 25 mg/mL Ophthalmic Solution because process deficiencies may have compromised the product's 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 recall is classified as FDA Class II and involves a risk of serious injury (infection) due to compromised sterility, which aligns with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Liberty Drug & Surgical is recalling Vancomycin 25 mg/mL Ophthalmic Solution, packaged in 10 mL and 15 mL bottles. The recall involves three specific bottles with lot numbers 06042015@15, 06052015@3, and 06082015@21. The product is prescription-only and was distributed to physicians, medical facilities, and specific patients in New Jersey and New York.
The recall was initiated due to process deficiencies observed in the sterile ophthalmic and injectable products. These deficiencies could have compromised the sterility of the product, posing a risk of infection to patients using the solution.
Patients who have received this medication should contact their healthcare provider for guidance on alternative treatments or further evaluation. The recalled product should be returned to the pharmacy or medical facility where it was dispensed.
The recalled product
- Product
- Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
- Manufacturer
- Liberty Drug & Surgical
- Category
- Drug — Ophthalmic Solution
- Affected units
- 3
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 (6)
- Lot #: a) 06042015@15
- Exp 06/18/15
- 06052015@3
- Exp 06/19/15
- b) 06082015@21
- Exp 06/22/15
Distribution
Part of a larger recall action
This product is one of 25 recalled by Liberty Drug & Surgical 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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