The Recall Desk

FDA (Drugs) recall action 73090

Abbott's Compounding Pharmacy, Inc. recalled 43 products on 2016-02-24

The FDA (Drugs) publishes a recall like this one as 43 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 43 pages.

Products
43
Announced
2016-02-24
Critical
0
Units

Why these products were recalled

Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

26–43 of 43

  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Hydroxycobalamine Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded Hydroxycobalamine 30 mg/mL in California due to FDA inspection findings regarding lack of sterility assurance.

    Product
    Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, due to FDA inspection findings regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine prostaglandin, after FDA inspection found lack of sterility assurance.

    Product
    papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products containing papaverine, phentolamine, and prostaglandin due to FDA inspection findings regarding sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL; 5 mL, 7 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, after FDA inspection found concerns regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded testosterone cypionate because an FDA inspection found concerns regarding the lack of sterility assurance.

    Product
    testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Methylcobalamine Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of methylcobalamine 1 mg/mL in California due to FDA inspection findings regarding lack of sterility assurance.

    Product
    methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, due to FDA inspection findings regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Methylcobalamine Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile methylcobalamine injections because an FDA inspection found concerns regarding the assurance of sterility.

    Product
    methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after an FDA inspection identified concerns regarding the assurance of sterility.

    Product
    papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Folic Acid Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded Folic Acid, 10 mg/mL, after an FDA inspection identified concerns regarding the assurance of sterility.

    Product
    Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Bupivacaine Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of Bupivacaine 0.25% sterile compounded products because an FDA inspection found concerns regarding the lack of sterility assurance.

    Product
    Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Insulin 70/30 Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded Insulin 70/30 after FDA inspection found concerns regarding the lack of sterility assurance.

    Product
    Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine, after FDA inspection found concerns regarding lack of sterility assurance.

    Product
    papaverine phentolamine, 35 mg/2.5 mg/mL; 5 mL unit size; refrigerate,This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Papaverine Prostaglandin Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of papaverine prostaglandin 30 mg/30 mcg/mL in California due to FDA inspection findings regarding lack of sterility assurance.

    Product
    papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products due to FDA inspection findings regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns regarding the assurance of sterility.

    Product
    papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Distribution
    1 state