The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1192-2015·Announced 2015-07-08

Lincare Recalls Vancomycin HCl/Heparin Due to Sterility Concerns

Lincare, Inc. is recalling Vancomycin HCl/Heparin compounded by United Medical IV Center 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 severity score under the rubric for drug recalls involving potential health risks.

Plain-English summary

Lincare, Inc. is recalling Vancomycin HCl/Heparin (Vancomycin 50mcg/mL / Heparin 100u/mL), a prescription-only compounded medication. The product was compounded by United Medical IV Center in Little Rock, Arkansas, on May 27, 2015, with a discard after date of June 10, 2015.

The recall was initiated because the sterility of the product is not assured. This lack of assurance of sterility poses a potential risk to patients using the medication.

The affected units were distributed in the United States, including Arkansas. Patients who have received this specific compounded medication should contact their healthcare provider or Lincare, Inc. for further instructions on how to proceed.

The recalled product

Product
Vancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin 100u/mL, Qty: 3, 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 — Compounded Medication
Hazard
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 (2)

  • Compounded on 05/27/15
  • Discard After: 06/10/15

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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