The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1204-2015·Announced 2015-07-08

Lincare Recalls Ganciclovir Sodium Bags Due to Sterility Concerns

Lincare, Inc. is recalling specific lots of Ganciclovir Sodium IV bags 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. According to the rubric, FDA Class II recalls involving significant injury reports or structural defects are rated Severe (4). While specific injury reports are not detailed in the snippet, the lack of sterility assurance in an IV product is a significant health risk consistent with the Severe category for Class II drug recalls.

Plain-English summary

Lincare, Inc. is recalling Ganciclovir Sodium, 250MG / NS 100ML, Rx Only, compounded by United Medical IV Center in Little Rock, Arkansas. The recall involves 6 100 mL bags per lot, compounded on 05/29/15, with a discard after date of 06/12/15.

The FDA has classified this as a Class II recall due to a lack of assurance of sterility. The source text states that the sterility of the product is not assured, which poses a risk of infection to patients receiving the medication.

The product was distributed in the United States, including Arkansas. Patients and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions.

The recalled product

Product
Ganciclovir Sodium, 250MG / NS 100ML, QTY: 6 100 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 Infusion
Hazard
Affected units
6

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 · sterility

See all →

Similar recalls