Recalls for Hospira

Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials
04/24/2015 Medical Recall

Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue.

  • Company:
    Hospira
Lactated Ringer's Irrigation, 3000mL by Hospira: Recall - Mold Contamination
03/12/2015 Medical Recall

Contaminated solution used on a patient may result in bacteremia, sepsis, septic shock and endocarditis, and death may result.

  • Company:
    Hospira
Hospira Issues a Voluntary Nationwide Recall of One Lot of Lactated Ringer's Irrigation Due to Mold Contamination
03/11/2015 Food Recall

Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary recall of one lot of Lactated Ringer's Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report of several dark, fibrous particulates floating within the solution of the primary container. The particulate was confirmed as a common non-toxic, non-invasive mold, Aspergillus kanagawaensis.

  • Company:
    Hospira
  • Problem
    Undeclared Milk And Wheat
Hospira Issues a Voluntary Nationwide Recall of One Lot of Magnesium Sulfate in 5% Dextrose Injection Due to Incorrect Barcode Labeling
03/06/2015 Food Recall

Hospira, Inc., (NYSE: HSP) has announced a voluntary recall of one lot of Magnesium Sulfate in 5% Dextrose, Inj., USP, 10 mg/mL (NDC: 0409-6727-23, Lot 42-120-JT, Expiry 1DEC2015) to the user level due to confirmed customer reports of an incorrect barcode on the primary bag labeling. The barcode on the overwrap is correct; however, there is potential for the primary container barcode to be mislabeled with the barcode for Heparin Sodium 2000 USP units/1000 mL in 0.9% Sodium Chloride Inj. The product is labeled with the correct printed name on the primary container and overwrap.

  • Company:
    Hospira
  • Problem
    Risk Of Ingestion
0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira: Recall - Particulate Matter
03/06/2015 Medical Recall

Injected particulate material may result in localized inflammation, phlebitis, allergic reaction, granuloma formation or microembolic effects, and/or low-level allergic response.

  • Company:
    Hospira
Ketorolac Tromethamine Injection by Hospira: Recall - Particulate in Glass Vials
02/11/2015 Medical Recall

Administration of particulates has the potential for localized inflammation, allergic reaction, granuloma formation, microembolic effects, or delay of therapy.

  • Company:
    Hospira
0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate Matter
01/23/2015 Medical Recall

Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response.

  • Company:
    Hospira
Mitoxantrone by Hospira: Recall - Confirmed Subpotency and Out-Of-Specification
12/24/2014 Medical Recall

Potential for decreased potency which can lead to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity requiring medical intervention.

  • Company:
    Hospira
Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter
10/17/2014 Medical Recall

Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects.

  • Company:
    Hospira
Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall - Particulate Matter
09/12/2014 Medical Recall

Risk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response.

  • Company:
    Hospira
Lidocaine HCI Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates
07/30/2014 Medical Recall

Injected particulate could result in delay in therapy, local inflammation, mechanical disruption of tissue or immune response to the particulate.

  • Company:
    Hospira
Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates
06/18/2014 Medical Recall

Injected particulate could result in blocked administration of the drug to the patient, causing a delay in therapy.

  • Company:
    Hospira
Hospira Announces Voluntary Nationwide Recall Of One Lot Of Labetalol Hydrochloride Injection, USP, 100 MG/20 ML (5MG/ML), 20 ML, Multidose Vial, Due To Visable Particulates
05/16/2014 Food Recall

Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall to the user level for one lot of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL) 20 mL Multidose Vial, NDC 0409-2267-20, Lot 36-225-DD, Expiration 12/01/2015.

  • Company:
    Hospira
  • Problem
    Punctures In The Pouch Packaging
Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates
04/22/2014 Medical Recall

Injected particulate could result in local inflammation, mechanical disruption of tissue or immune response to the particulate.

  • Company:
    Hospira
Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates
04/18/2014 Medical Recall

Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate.

  • Company:
    Hospira
Hospira Issues a Voluntary Nationwide Recall of One Lot of Lidocaine HCl Injection, USP, 2%, 5 Ml in 5 Ml Vial, Due to Presence of Particulate Matter
12/23/2013 Food Recall

Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall to the user level for one lot of Lidocaine HCl Injection, USP, 2%, 5 mL Single-Dose Vial (NDC 0409-2066-05), Lot 32-135-DD, expiration date 1AUG2015. The recall is due to a reddish orange particulate on the inner surface and floating in the solution.

  • Company:
    Hospira
Hospira GemStar Infusion System: Class I Recall - Pressure Sensor Calibration Drift
11/25/2013 Medical Recall

May result in a delay, interruption or over-infusion in therapy, which have a worst case potential to result in significant injury or death depending on the drug and the dosage administered.

  • Company:
    Hospira
Hospira Issues a Voluntary Nationwide Recall of One Lot of 0.25% Marcaine™ (Bupivacaine HCL Injection, USP), 75mg/30ml, Single-Dose - Preservative Free Vial Due to Presence of Particulate Matter
10/18/2013 Food Recall

Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine™ (Bupivacaine HCl Injection, USP), 75 mg/30 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-30), Lot 25-220-DD. The recall is due to a confirmed customer report of discolored solution with visible particles inside the glass vial as well as embedded in the glass.

  • Company:
    Hospira
1% Lidocaine HCL Injection By Hospira: Recall - Presence Of Dark Particulate
10/05/2013 Medical Recall

May result in local inflammation, phlebitis, and/or low-level allergic response, and could block administration of the drug to the patient, causing a delay in therapy.

  • Company:
    Hospira
Hospira Issues A Voluntary Nationwide Recall Of One Lot Of 1% Lidocaine HCL Injection Due To The Presence Of Dark Particulate
10/04/2013 Food Recall

Hospira, Inc.(NYSE: HSP), announced today it has initiated a voluntary nationwide recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 20 mL Multiple-dose Fliptop Vial, NDC 0409-4276-01 Lot 25-090-DK (the lot number may be followed by 01 or 02).

  • Company:
    Hospira
Metoclopramide Injection And Ondansetron Injection by Hospira: Recall - Glass Strand Particulates Caused By Glass Supplier
10/02/2013 Medical Recall

Administration of an injectable with the presence of foreign particulates may result in local inflammation, thrombophlebitis, and/or low-level allergic response.

  • Company:
    Hospira
HOSPIRA ISSUES A VOLUNTARY NATIONWIDE RECALL OF ONE LOT OF METOCLOPRAMIDE INJECTION, USP, AND TWO LOTS OF ONDANSETRON INJECTION, USP, DUE TO GLASS (GLASS STRANDS) PARTICULATES CAUSED BY GLASS SUPPLIER DEFECT
10/02/2013 Food Recall

Hospira, Inc. (NYSE: HSP), announced today it initiated a voluntary nationwide recall of one lot of Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL), NDC 0409-3414-01, Lot 28-104-DK and two lots of Ondansetron Injection, USP, 4 mg/2 mL, (2 mg/mL), NDC 0409-4755-03, Lots 29-484-DK and 29-510-DK. This action is due to a confirmed vial defect where glass particulate matter (glass strands) were identified as being affixed to the inside of the vial walls. There is potential for the glass particulates to dislodge into the solution.

  • Company:
    Hospira
Aminosyn II 10 percent, Sulfite-Free (Hospira): Recall - Particulate Matter Noted in One Lot
09/03/2013 Medical Recall

Particle confirmed by Hospira as human hair.

  • Company:
    Hospira
Hospira Blood Sets: Recall - Instances Of Outer Wall Of Blood Bags Punctured With Piercing Pin
08/14/2013 Medical Recall

Spillage of the blood and blood products stored in the bag may result in delay/interruption in therapy or exposure to the healthcare professional.

  • Company:
    Hospira