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.
- 2019-12-18FDA-DrugCoast Quality Pharmacy, LLC dba Anazao HealthClass IIMorphine Sulfate and Bupivacaine 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 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 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 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 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 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 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 IIFentanyl 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 IIBupivacaine HCl and Hydromorphone 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 IIBupivacaine HCL and Clonidine HCL and Hydromorphone 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 IIBupivacaine HCL and Clonidine HCL and Hydromorphone 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 IIBaclofen 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 IIBaclofen 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/Hydromorphone 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 IIGlutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 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 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-DrugPfizer Inc.Class II25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10
Labeling: Incorrect or Missing Lot and/or expiration date.
- 2019-12-18FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIAmantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
- 2019-12-18FDA-DrugAuroMedics Pharma LLCClass IIVancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.
Discoloration: Product complaints of discoloration after reconstitution of vials.
- 2019-12-11FDA-DrugPacira Pharmaceuticals, Inc.Class IIEXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20,
Sub Potent Drug: Out of Specification (OOS)
- 2019-12-11FDA-DrugAuroMedics Pharma LLCClass IIFluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ
Discoloration; Hazy solution found in one vial instead of a clear solution.
- 2019-12-11FDA-DrugQuVa Pharma, Inc.Class IIfentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1274-50
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- 2019-12-11FDA-DrugQuVa Pharma, Inc.Class IIfentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1250-75
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- 2019-12-11FDA-DrugQuVa Pharma, Inc.Class IIfentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1180-79
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- 2019-12-11FDA-DrugQuVa Pharma, Inc.Class IIfentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- 2019-12-11FDA-DrugQuVa Pharma, Inc.Class IIfentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- 2019-12-11FDA-DrugQuVa Pharma, Inc.Class IIfentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1444-05
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- 2019-12-11FDA-DrugQuVa Pharma, Inc.Class IIfentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1415-47
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- 2019-12-11FDA-DrugQuVa Pharma, Inc.Class IIfentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1103-36
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- 2019-12-11FDA-DrugQuVa Pharma, Inc.Class IIfentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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