The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1167-2015·Announced 2015-07-08

Lincare Recalls Vancomycin IV Bags Due to Sterility Concerns

Lincare, Inc. is recalling Vancomycin HCl in Dextrose IV bags because the sterility of the product is not assured. The affected bags were compounded 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance in IV products) are rated as Severe (4), especially given the risk of infection from non-sterile IV administration.

Plain-English summary

Lincare, Inc. is recalling Vancomycin HCl in Dextrose, VANCOMYCIN 500mg / D5W 100mL AccuFlo, Qty: 12 100 mL Bags. The recall was initiated because the sterility of the product is not assured. The product was compounded by United Medical IV Center in Little Rock, Arkansas, on May 29, 2015, with a discard after date of June 12, 2015.

The affected product was distributed in the United States, including Arkansas. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or Lincare, Inc. for further instructions. The product is prescription-only.

The recalled product

Product
Vancomycin HCl in Dextrose, VANCOMYCIN 500mg / D5W 100mL AccuFlo, Qty: 12 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
Manufacturer
Lincare, Inc.
Category
Drug — IV Infusion
Hazard
Affected units
12

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 05/29/15
  • Discard After: 06/12/15

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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