The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1181-2015·Announced 2015-07-08

Lincare Recalls Vancomycin Syringes Due to Sterility Assurance Concerns

Lincare, Inc. is recalling Vancomycin HCL 250mg syringes compounded by United Medical IV Center in Arkansas because the sterility of the product is not assured.

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, which corresponds to a 'Severe' rating under the rubric, particularly given the lack of assurance of sterility in a medical product.

Plain-English summary

Lincare, Inc. is recalling Vancomycin HCL 250mg / NS 6mL syringes, which are prescription-only medications packaged in 6 mL syringes. The affected products were compounded by United Medical IV Center in Little Rock, Arkansas, on May 27, 2015, and have a discard-after date of June 6, 2015.

The recall was initiated because the sterility of the product is not assured. This classification indicates a potential risk of contamination, although the source text does not specify the nature of the contamination or report any specific illnesses or injuries.

The recall is classified as FDA Class II. The distribution pattern includes the United States, specifically Arkansas. Consumers and healthcare providers should stop using the affected syringes and contact their healthcare provider or Lincare, Inc. for further instructions or replacement.

The recalled product

Product
VANCOMYCIN HCL 250mg / NS 6mL syringe, Packaged in 6 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

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: 06/06/2015

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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