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    NEWS

    DRUGS & DEVELOPMENTS

    MARKET INTEL by PharmaCompass

    AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.
    All News #Library
    Quality

    Pfizer`s Hospira pulls 5 lots of hospital injectable drugs

    FIERCE PHARMA

    Pfizer`s Hospira rings in new year with fresh round of recalls

    FIERCE PHARMA

    Recall report: Amino acid IV pulled after foreign substances found in batch

    ENDPTS

    Hospira, Inc., et al.; Withdrawal of Approval of 15 Abbreviated NDA

    AMAZONAS

    Company led drug alert Paclitaxel 6 mg/ml concentrate for solution for infusion

    GOV

    Mylan, Hospira both recall injected drugs after particulate discovered in vials

    FIERCE PHARMA

    FDA issues warning letter to India plant Pfizer is closing

    FIERCE PHARMA

    Pfizer still unable to get on top of problems at Hospira injectables plant

    FIERCE PHARMA

    An FDA inspection report shows just how troubled a Pfizer plant really is

    STAT NEWS

    FDA Flags Pfizer’s Hospira Plant in Kansas Over Repeat 483 Citations

    RAPS

    Pfizer responds to FDA, EMA and Canada after plant reinspections

    FIERCE PHARMA

    Hospira recall of vials adds to woes of sodium bicarbonate shortage

    FIERCE PHARMA

    Pfizer recalls injectables made at Rocky Mount over potential contamination risk

    IN PHARMATECHNOLOGIST

    Pfizer ‘disappointed’ with US FDA outcome at ex-Hospira plant

    IN PHARMATECHNOLOGIST

    Pfizer Kansas Plant is `Out of Control` ,Patients at Risk, Says the FDA

    BIOSPACE

    Pfizer hit with US FDA warning at Kansas generic Copaxone site

    IN PHARMATECHNOLOGIST

    Mezzion sues Dr. Reddy`s for Fraud

    FIERCE PHARMA

    Concerns at Wockhardt, Hospira Plants Factor into CRL issued to Cempra

    FIERCE PHARMA

    U.K. marketing cops slap Hospira, Napp for `improper` biosim promo meetings

    FIERCE PHARMA

    UK MHRA strips Pfizer-owned India antibiotics plant of GMP certificate

    IN PHARMATECHNOLOGIST

    Hospira gives Pfizer big Q2 revenue boost as new brands Ibrance, Xeljanz

    FIERCE PHARMA

    FDA Extends Use Dates for Pfizer Injectables to Ease Shortage

    RAPS

    Hospira manufacturing mess-up leads to PharMEDium recalls

    FIERCE PHARMA MANUFACTURING

    FDA Drug Shortages: Sufentanil Citrate (Sufenta) Injection

    FDA

    FDA Drug Shortages: Fentanyl Citrate (Sublimaze) Injection

    FDA

    Meropenem for Injection is currently in shortage due to increased demand

    FDA

    FDA Warns Hospitals to Stop Using Medical Device Vulnerable to Hackers

    NBC BAY AREA

    Citing Hacking Risk, FDA Says Hospira Pump Shouldn`t Be Used

    THE NEW YORK TIMES

    NICE recommends infliximab biosimilars ahead of Remicade

    PM LIVE

    Top Class I drug recallers

    FIERCE PHARMA MANUFACTURING

    Warning Letters Cite Items not Included in the Form FDA-483

    UNGER CONSULTING

    Awesome Baby; We Love This Game! An Update on Pending Hatch-Waxman and BPCIA Litigation

    FDA LAW BLOG

    Hospira Inc., Ongoing Class II recall of 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-04), UPC (01)003040971000040, packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx only, Hospira, Inc., Lake Forest, IL 60045. because of Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.

    FDA

    FDA Drug Shortages: Vancomycin Hydrochloride for Injection, USP

    FDA

    FDA Drug Shortages: Tobramycin Injection

    FDA

    FDA Drug Shortages: Sodium Chloride 23.4% Injection

    FDA

    FDA Drug Shortages: Potassium Chloride Injection

    FDA

    FDA Drug Shortages: Piperacillin and Tazobactam (Zosyn) Injection

    FDA

    FDA Drug Shortages: Magnesium Sulfate Injection

    FDA

    FDA Drug Shortages: Lidocaine Hydrochloride (Xylocaine) Injection

    FDA

    FDA Drug Shortages: Ketorolac Tromethamine Injection

    FDA

    FDA Drug Shortages: Cefazolin Injection

    FDA

    FDA Drug Shortages: Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection

    FDA

    U.S. Sterile Manufacturer Racks Up 13 Observations In FDA Visit

    FIERCE PHARMA

    Hospira Issues a Voluntary Nationwide Recall of One Lot of Lactated Ringer`s Irrigation Due to Mold Contamination Photo

    FDA

    Hospira Inc., Ongoing Class II recall of Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01. because of Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

    FDA

    Hospira Inc., Ongoing Class I recall of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. because of Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

    FDA

    Hospira Inc., Ongoing Class II recall of Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01. because of Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

    FDA

    Hospira Inc., Ongoing Class II recall of Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01. because of Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

    FDA

    Hospira Inc., Ongoing Class I recall of 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045 because of Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.

    FDA

    Hospira Inc., Ongoing Class I recall of LACTATED RINGER`S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09 because of Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.

    FDA

    Remicade`s U.S. Patent Rejection Could Open Up Early Rivalry with Celltrion Biosim

    FIERCE PHARMA

    Recall: Cefazoline for Injection

    HEALTHY CANADIANS

    Hospira Issues a Voluntary Global Recall of Multiple Lots of Ketorolac Tromethamine Injection Due to Potential Particulate in Glass Vials

    FDA

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