The Recall Desk
SevereFDA (Drugs)·D-1199-2015·Announced 2015-07-08

Lincare Recalls Cefepime HCl IV Bags Due to Sterility Concerns

Lincare, Inc. is recalling Cefepime HCl IV bags compounded by United Medical IV Center because the sterility of the product is not assured.

What this means for you

Illness, injury, or structural failure has been reported. 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 significant injury or hospitalization (implied by lack of sterility in IV products) are rated as Severe.

Plain-English summary

Lincare, Inc. is recalling Cefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 mL Bags. The product was compounded by United Medical IV Center in Little Rock, Arkansas. The recall was initiated because the sterility of the product is not assured.

The affected product was compounded on May 29, 2015, and has a discard after date of June 12, 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 Lincare, Inc. for further instructions.

The recalled product

Product
Cefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 mL Bags, 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 — IV Compounded
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 →

Related recalls

Same manufacturer · Lincare, Inc.

See all →

Same hazard · lack of sterility

See all →