The Recall Desk
SevereFDA (Drugs)·D-1387-2015·Announced 2015-09-02

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.

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: 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.
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

Distributed in 2 states:

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.

See all 25 products in this recall →