The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1194-2015·Announced 2015-07-08

Lincare Recalls Pfizerpen-G IV Bags Due to Sterility Concerns

Lincare, Inc. is recalling Pfizerpen-G IV bags compounded by United Medical IV Center 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, and the hazard involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or infection.

Plain-English summary

Lincare, Inc. is recalling Pfizerpen-G 4.2 MU / SW 240 mL AccuFlo, packaged in 2 240 mL bags, which is a prescription-only medication. The product was compounded by United Medical IV Center in Little Rock, Arkansas.

The recall was initiated due to a lack of assurance of sterility, meaning the sterility of the product is not assured. The affected units were compounded on May 29, 2015, and have a discard-after date of June 12, 2015.

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

The recalled product

Product
Pfizerpen-G 4.2 MU / SW 240 mL AccuFlo, Packaged in 2 240 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
2

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 05/29/2015
  • Discard After: 06/12/2015

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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