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High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF ...
Medical Devices·30,541 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S4...
Medical Devices·37,721 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS...
Medical Devices·23,850 affected·Feb 8, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S431...
Medical Devices·186,889 affected·Feb 8, 2023
High RiskFDA
Texas Star Nut And Food Co., Inc.
Nature's Eats Cashew Crave Mix 8 oz. UPC 8-10087-30330-3, packaged in cello bags 12 packages per case
Food·19,800 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufacture...
Oral Drugs·113,571 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729...
Oral Drugs·72,376 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufact...
Oral Drugs·25,812 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle...
Oral Drugs·665,469 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 167...
Oral Drugs·147,736 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured b...
Oral Drugs·2,614 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: ...
Oral Drugs·139,332 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) 500 Tablets NDC ...
Oral Drugs·24,408 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 1...
Oral Drugs·256,106 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufacture...
Oral Drugs·1,970 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured for: Accord Healthc...
Injectable Drugs·3,164 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16...
Oral Drugs·176,323 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count bottle, NDC ...
Oral Drugs·539,004 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-count bottle NDC 1...
Oral Drugs·469,944 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 1...
Oral Drugs·312,864 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets ND...
Oral Drugs·1,190,484 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by:...
Oral Drugs·1,440,652 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC ...
Oral Drugs·36,773 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactur...
Oral Drugs·120 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets NDC 16729-415-17...
Oral Drugs·31,116 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-count bottle NDC 167...
Oral Drugs·44,068 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles ...
Oral Drugs·43,302 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC...
Injectable Drugs·9,888 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: In...
Oral Drugs·25,344 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufac...
Oral Drugs·3,784 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Inta...
Oral Drugs·5,112 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Int...
Oral Drugs·14,928 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufa...
Oral Drugs·23,784 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas ...
Oral Drugs·2,641 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Ac...
Injectable Drugs·48,089 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Int...
Oral Drugs·104,945 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-count bottle NDC 1...
Oral Drugs·1,394,208 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durh...
Injectable Drugs·37,691 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-3...
Injectable Drugs·228,760 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) 10 Single-dose v...
Injectable Drugs·65,233 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcar...
Injectable Drugs·322 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-count bottle NDC 16...
Oral Drugs·256,648 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 1...
Oral Drugs·205,631 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count bottle ND...
Oral Drugs·291,378 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 1...
Oral Drugs·613,553 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-count NDC 16729-414...
Oral Drugs·69,122 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-count bottle NDC 1...
Oral Drugs·102,360 affected·Feb 7, 2023
High RiskFDA
Accord Healthcare, Inc.
Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16...
Oral Drugs·241,585 affected·Feb 7, 2023