The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1178-2015·Announced 2015-07-08

Lincare Recalls Hydrocodone IV Bags Due to Sterility Concerns

Lincare, Inc. is recalling specific lots of Hydromorphone HCl 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection from non-sterile IV products.

Plain-English summary

Lincare, Inc. is recalling specific lots of Hydromorphone HCl 1000mg/500mL IV bags. The recall was initiated because the sterility of the product is not assured. The affected product was compounded by United Medical IV Center in Little Rock, Arkansas, and distributed in the United States, including Arkansas.

The specific product is identified as Hydromorphone HCl PF, 1000mg in 500mL of Normal Saline, compounded on May 27, 2015, with a discard after date of June 24, 2015. This is a prescription-only medication.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or Lincare, Inc. for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
HYDROmorphone HCl PF, HYDROMORPHONE HCL 1000mg /NS 500mL, Qty: 1 500 mL Bag, 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
1

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 05/27/15
  • Discard After: 06/24/15

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 · infection

See all →

Similar recalls