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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05 AuroMedics Pharma LLC Class I Terminated 20191218
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05 AuroMedics Pharma LLC Class I Terminated 20191218
Petroleum 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 OraLabs, Incorporated Class II Terminated 20191218
Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09 SCA Pharmaceuticals, LLC Class II Terminated 20191218
Clobetasol 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 Glenmark Pharmaceuticals Inc., USA Class III Terminated 20191218
Clobetasol 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 Glenmark Pharmaceuticals Inc., USA Class III Terminated 20191218
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals Preferred Pharmaceuticals, Inc Class II Terminated 20191218
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02. Amneal Pharmaceuticals, Inc. Class II Ongoing 20191218
Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10. Amneal Pharmaceuticals, Inc. Class II Ongoing 20191218
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90. Amneal Pharmaceuticals, Inc. Class II Ongoing 20191218
Ranitidine 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). Amneal Pharmaceuticals, Inc. Class II Ongoing 20191218
Ranitidine 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). Amneal Pharmaceuticals, Inc. Class II Ongoing 20191218
Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.AVE. CHATT,TN37409 Surgery Pharmacy Services Inc Class II Terminated 20191218
Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., CHATTANOOGA, TN., 37409, Surgery Pharmacy Services Inc Class II Terminated 20191218
Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Hydromorphone 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. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Morphine 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 Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Sufentanil 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. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Clonidine 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 Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Morphine Sulfate and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Bupivacaine 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. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Baclofen and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Coast Quality Pharmacy, LLC dba Anazao Health Class II Terminated 20191218
25% 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 Pfizer Inc. Class II Terminated 20191218
Amantadine 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. Jubilant Cadista Pharmaceuticals, Inc. Class II Terminated 20191218
Vancomycin 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. AuroMedics Pharma LLC Class II Terminated 20191218
EXPAREL, 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, Pacira Pharmaceuticals, Inc. Class II Terminated 20191211
Fluphenazine 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 AuroMedics Pharma LLC Class II Terminated 20191211