The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1182-2015·Announced 2015-07-08

Lincare Recalls Compounded Vancomycin and Heparin Due to Sterility Concerns

Lincare, Inc. is recalling compounded Vancomycin and Heparin products because the sterility of the product is not assured. The recall affects products 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 health consequences (such as lack of sterility assurance in IV products) align with a Severe rating, particularly given the risk of infection from non-sterile injectable products.

Plain-English summary

Lincare, Inc. is recalling specific units of VANC 50MCG/ML-HEP 100U/ML in 2ML, packed in 2 mL units, which are prescription-only. The product was compounded by United Medical IV Center in Little Rock, Arkansas. The recall is issued because the sterility of the product is not assured.

The affected products were compounded on May 27, 2015, and have a discard-after date of June 11, 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 pharmacist for further instructions. No specific illness or injury reports are mentioned in the source text.

The recalled product

Product
VANC 50MCG/ML-HEP 100U/ML in 2ML, Packed in 2 mL Units, 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 IV
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: 06/11/2015

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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