Hospira A Pfizer recalls
Hospira A Pfizer appears in 14 official U.S. recall notices indexed by RecallRadar, most recently on 2018-03-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 14 |
|---|---|
| Published | 2016-09-21 to 2018-03-14 |
| By agency | FDA Drug (12), FDA Device (2) |
| By classification | Class II (11), Class I (2), Class III (1) |
| By status | terminated (13), ongoing (1) |
| Distribution named in notices | CT, HI, IA, MA, ME, MI, MN, ND, NJ, NY, PA, PR, TX, US, WI |
Recalls
- Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, I…
FDA Drug · Class II · 2018-03-14 · Hospira A Pfizer
Reason: Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal. - Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer
Reason: Lack of Sterility Assurance - Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx On…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer
Reason: Lack of Sterility Assurance - 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer
Reason: Lack of Sterility Assurance - Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer
Reason: Lack of Sterility Assurance - Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad,…
FDA Drug · Class III · 2017-07-26 · Hospira A Pfizer
Reason: Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point - Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc
FDA Drug · Class II · 2017-06-21 · Hospira A Pfizer
Reason: GMP Deviation; A foreign stopper was observed during packaging of a lot of product. - Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 10…
FDA Drug · Class I · 2017-04-12 · Hospira A Pfizer
Reason: Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product. - Plum 360 Infusion Pump, Software Version 15.02
FDA Device · Class II · 2017-04-05 · Hospira A Pfizer
Reason: Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy c… - METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL…
FDA Drug · Class II · 2017-03-01 · Hospira A Pfizer
Reason: Lack of Sterility Assurance: customer report of leaking bag - Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake…
FDA Drug · Class I · 2016-12-28 · Hospira A Pfizer
Reason: Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial. - Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, I…
FDA Drug · Class II · 2016-10-19 · Hospira A Pfizer
Reason: Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency. - Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 6…
FDA Drug · Class II · 2016-10-19 · Hospira A Pfizer
Reason: Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency. - Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the Sapphir…
FDA Device · Class II · 2016-09-21 · Hospira A Pfizer
Reason: Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units.