December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoov
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Morphine Sulfate and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa,
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa,
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 57
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all strengths, all doses and all packagi
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Baclofen and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 336
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 3
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tamp
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, F
Hazard: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
December 18, 2019DrugsFDA
Pfizer Inc. recalls 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA,
Hazard: Labeling: Incorrect or Missing Lot and/or expiration date.
December 18, 2019DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-24
Hazard: Presence of Foreign Substance: Presence of a foreign object in a single tablet.
December 18, 2019DrugsFDA
AuroMedics Pharma LLC recalls Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in Indi
Hazard: Discoloration: Product complaints of discoloration after reconstitution of vials.
December 11, 2019DrugsFDA
Pacira Pharmaceuticals, Inc. recalls EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufa
Hazard: Sub Potent Drug: Out of Specification (OOS)
December 11, 2019DrugsFDA
AuroMedics Pharma LLC recalls Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for:
Hazard: Discoloration; Hazy solution found in one vial instead of a clear solution.
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Pa
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Pa
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 10
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Su
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 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
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
December 11, 2019DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park
Hazard: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules