The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1195-2015·Announced 2015-07-08

Lincare Recalls Gentamicin Syringes Due to Sterility Concerns

Lincare, Inc. is recalling Gentamicin 14.4 mg syringes because the sterility of the product is not assured. The recall affects 2 syringes distributed in Arkansas.

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 the rubric specifies that FDA Class II recalls with potential for serious injury or hospitalization (implied by lack of sterility assurance in a medical drug) fall under the Severe category.

Plain-English summary

Lincare, Inc. is recalling Gentamicin 14.4 mg / NS 30 mL Syringes, which are prescription-only products compounded by United Medical IV Center in Little Rock, Arkansas. The recall was initiated because the sterility of the product is not assured.

The affected product consists of 2 syringes compounded on May 27, 2015, with a discard after date of June 24, 2015. The distribution pattern includes the United States, specifically Arkansas.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or Lincare, Inc. for further instructions or a replacement.

The recalled product

Product
GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Packaged in 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Manufacturer
Lincare, Inc.
Category
Drug — Antibiotic
Hazard
Affected units
2

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)

  • Compounded on 05/27/2015
  • Discard After: 06/24/2015

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 54 recalled by Lincare, Inc. 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 54 products in this recall →

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