Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-12-25FDA-DrugMedisca, Inc.Class IIEstriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA
Failed Impurities/Degradation Specifications
- 2019-12-18FDA-DrugAuroMedics Pharma LLCClass IMirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
- 2019-12-18FDA-DrugAuroMedics Pharma LLCClass IMirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
- 2019-12-18FDA-DrugOraLabs, IncorporatedClass IIPetroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884), b) 2.5 oz tube (UPC 1182298541), Distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011
Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.
- 2019-12-18FDA-DrugSCA Pharmaceuticals, LLCClass IILidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
- 2019-12-18FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIIClobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Defective delivery system; product is not foaming or is coming out as liquid.
- 2019-12-18FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIIClobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra, India Manufactured for: Glenmark Pharmaceuticas Inc. USA Mahwah, NJ 07430
Defective delivery system; product is not foaming or is coming out as liquid.
- 2019-12-18FDA-DrugPreferred Pharmaceuticals, IncClass IIRanitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.
- 2019-12-18FDA-DrugAmneal Pharmaceuticals, Inc.Class IIRanitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- 2019-12-18FDA-DrugAmneal Pharmaceuticals, Inc.Class IIRanitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- 2019-12-18FDA-DrugAmneal Pharmaceuticals, Inc.Class IIRanitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- 2019-12-18FDA-DrugAmneal Pharmaceuticals, Inc.Class IIRanitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- 2019-12-18FDA-DrugAmneal Pharmaceuticals, Inc.Class IIRanitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- 2019-12-18FDA-DrugSurgery Pharmacy Services IncClass IITrisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.AVE. CHATT,TN37409
Lack of sterility assurance.
- 2019-12-18FDA-DrugSurgery Pharmacy Services IncClass IIMemorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., CHATTANOOGA, TN., 37409,
Lack of sterility assurance.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIHydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIHydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIHydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIFentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIFentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIFentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIBaclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIMorphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIMorphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IISufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIClonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard) AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIClonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIClonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIClonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIMorphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
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