The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1035-2014·Announced 2014-02-05

Hospira Recalls Aminosyn 3.5% Bags Due to Sterility Concerns

Hospira Inc. is recalling 15,258 bags of Aminosyn 3.5% M Sulfite-Free due to a lack of assurance of sterility and potential leakage from the administrative port.

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 sterility failure in an intravenous product.

Plain-English summary

Hospira Inc. is recalling 15,258 bags of Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution with Maintenance Electrolytes with Phosphorus, 1000 mL bag. The product is prescription-only and was distributed nationwide, including Puerto Rico. The specific lot number is 26-123-JT with an expiration date of 8/14.

The recall was initiated due to a lack of assurance of sterility and the potential for leakage from the administrative port. This defect could compromise the safety of the intravenous solution.

Healthcare providers and patients should stop using the affected product immediately. Consumers should check their inventory for the specific lot number and expiration date listed above and contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05
Manufacturer
Hospira Inc.
Category
Drug — Intravenous Solution
Hazard
Affected units
15,258

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)

  • Lot #: 26-123-JT
  • Exp: 8/14

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Hospira 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 2 products in this recall →

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