The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1200-2015·Announced 2015-07-08

Lincare Recalls Morphine Sulfate Bags Due to Sterility Concerns

Lincare, Inc. is recalling specific compounded Morphine Sulfate bags because the sterility of the product is not assured. The affected bags were 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in IV products) are classified as Severe (Score 4), as they are not Class I but involve significant risk.

Plain-English summary

Lincare, Inc. is recalling a specific lot of compounded Morphine Sulfate 1000mg / NS 100mL bags. The recall is being conducted because the sterility of the product is not assured. The affected product was compounded by United Medical IV Center in Little Rock, Arkansas, on May 30, 2015, and had a discard after date of June 13, 2015.

The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The distribution pattern includes the United States, specifically Arkansas.

Consumers and healthcare providers should stop using the affected product and contact Lincare, Inc. or their healthcare provider for further instructions. The product is prescription-only and was distributed in 50 mL bags.

The recalled product

Product
Morphine Sulfate, MORPHINE SULFATE 1000mg / NS 100mL, Qty: 1 50 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 Compounded
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 05/30/15
  • Discard After: 06/13/15

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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