The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1189-2015·Announced 2015-07-08

Lincare Recalls Ceftriaxone Sodium Due to Sterility Concerns

Lincare, Inc. is recalling compounded Ceftriaxone Sodium IV bags because the sterility of the product is not assured. The recall affects units 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 involves a lack of assurance of sterility in an intravenous medication, which poses a significant risk of serious injury or hospitalization if contaminated.

Plain-English summary

Lincare, Inc. is recalling specific lots of Ceftriaxone Sodium, Ceftriaxone 2gm / NS 50mL, Rx Only. The product consists of 12 50 mL bags and 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 recall is classified as FDA Class II. Distribution was limited to the United States, specifically including Arkansas.

Patients who have received this medication should contact their healthcare provider for guidance. Consumers should not use the recalled product and should return it to the pharmacy or healthcare provider where it was obtained.

The recalled product

Product
Ceftriaxone Sodium, Ceftriaxone 2gm / NS 50mL, 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 — Antibiotic
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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