The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1166-2015·Announced 2015-07-08

Lincare Recalls Penicillin G Potassium IV Bags Due to Sterility Concerns

Lincare, Inc. is recalling Penicillin G Potassium IV bags 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 indicates a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences. The lack of sterility assurance in an IV medication poses a significant risk of infection, fitting the 'Severe' criteria for significant injury reports or high-risk contamination.

Plain-English summary

Lincare, Inc. is recalling specific lots of Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo IV bags. The product was compounded by United Medical IV Center in Little Rock, Arkansas, and is prescription-only. The recall involves 4-bag quantities.

The recall was initiated because the sterility of the product is not assured. This means there is a risk that the medication may contain microorganisms that could cause infection if administered to a patient.

The affected product was distributed in the United States, including Arkansas. The specific lots were compounded on May 29, 2015, with a discard-after date of June 12, 2015. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or Lincare, Inc. for further instructions.

The recalled product

Product
Penicillin G Potassium 5.4 MU/SW 240 mL AccuFlo, Qty: 4 240 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 — Antibiotic
Hazard
Affected units
4

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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