Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine 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
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine phentolamine, 35 mg/2.5 mg/mL; 5 mL unit size; refrigerate,This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIpapaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IImethylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IImethylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IImethylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIInsulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIhydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIhydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIHydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIFolic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIFolic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIEstradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIcalcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugAbbott's Compounding Pharmacy, Inc.Class IIBupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
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.
- 2016-02-24FDA-DrugInaffit, LLCClass INATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
- 2016-02-24FDA-DrugMedisca IncClass ICITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by Medisca Inc. Plattsburgh, NY 12901, USA, NDC #s: 38779-1186-4 (25 g), 38779-1186-5 (100 g), 38779-1186-8 (500 g), 38779-1186-9 (1 kg).
Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.
- 2016-02-24FDA-DrugPremiere Sales GroupClass IRhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA
Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
- 2016-02-24FDA-DrugPremiere Sales GroupClass IRhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
- 2016-02-24FDA-DrugMSNV, Inc dba National Video SupplyClass IRhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA
Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
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