Hospira Inc. A Pfizer recalls
FDA enforcement reports naming Hospira Inc. A Pfizer Company as the recalling firm.
- Recall reports
- 8
- Class I (serious)
- 2
- Most recent report
- Mar 14, 2018
- Mar 14, 2018Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial,…Drug · Hospira Inc. A Pfizer CompanyDefective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.Class II
- Jul 26, 2017Argatroban Injection, 250 mg/2Drug · Hospira Inc., A Pfizer CompanyFailed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time pointClass III
- Jun 21, 2017Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hosp…Drug · Hospira Inc., A Pfizer CompanyGMP Deviation; A foreign stopper was observed during packaging of a lot of product.Class II
- Apr 12, 2017Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For…Drug · Hospira Inc., A Pfizer CompanyPresence 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.Class I
- Mar 1, 2017METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container,…Drug · Hospira Inc., A Pfizer CompanyLack of Sterility Assurance: customer report of leaking bagClass II
- Dec 28, 2016Bupivacaine Hydrochloride InjDrug · Hospira Inc., A Pfizer CompanyPresence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.Class I
- Oct 19, 2016Marcaine 0Drug · Hospira Inc., A Pfizer CompanyLack 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.Class II
- Oct 19, 2016Marcaine 0Drug · Hospira Inc., A Pfizer CompanyLack 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.Class II