The Recall Desk
SevereFDA (Drugs)·D-1389-2015·Announced 2015-09-02

Liberty Drug Recalls Tobramycin Ophthalmic Solution Due to Sterility Concerns

Liberty Drug & Surgical is recalling Tobramycin 14 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 due to compromised sterility in an ophthalmic product, which aligns with the 'Severe' criteria for significant injury reports or high-risk defects.

Plain-English summary

Liberty Drug & Surgical is recalling specific bottles of Tobramycin 14 mg/mL Ophthalmic Solution. The recall was initiated because process deficiencies were observed in the sterile ophthalmic and injectable products, which could have compromised the sterility of the product.

The affected product is a 15 mL bottle of Tobramycin 14 mg/mL Ophthalmic Solution, which is prescription only. The specific lot number is 06082015@20, and the expiration date is 06/22/15. The product was distributed to physicians, medical facilities, and prescription-specific patients in New Jersey and New York.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Affected units
1

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 (2)

  • Lot #: 06082015@20
  • 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 →