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High RiskFDA
Par Formulations Private Limited
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A...
Oral Drugs·218 affected·Nov 10, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extensi...
Injectable Drugs·56,220 affected·Nov 10, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Col...
Injectable Drugs·34,020 affected·Nov 10, 2022
CriticalFDA
Ge Medical Systems, Llc
Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, tes...
Cardiac Devices·5,145 affected·Nov 10, 2022
CriticalFDA
Ge Medical Systems, Llc
Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric;...
Cardiac Devices·1,400 affected·Nov 10, 2022
CriticalFDA
Ge Medical Systems, Llc
Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, tes...
Cardiac Devices·5,649 affected·Nov 10, 2022
CriticalFDA
Ge Medical Systems, Llc
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultra...
Cardiac Devices·7,931 affected·Nov 10, 2022
RecallFDA
Lannett Company Inc.
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett C...
Oral Drugs·20,040 affected·Nov 9, 2022
High RiskFDA
Imprimisrx Nj
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
Ophthalmic Drugs·960 affected·Nov 9, 2022
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 09...
Injectable Drugs·137,120 affected·Nov 9, 2022
High RiskFDA
Discovery Pharma Llc
Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum, Topical Cream, Net weight 0.78 oz (22g) tube, UPC 8...
Topical Drugs·21,892 affected·Nov 9, 2022
RecallFDA
Lannett Company Inc.
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, In...
Oral Drugs·5,640 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
Medical Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
Medical Devices·10 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
Medical Devices·4 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012
Medical Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
Diagnostic Devices·15 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
Medical Devices·0 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
Medical Devices·2 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
Diagnostic Devices·64 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012
Medical Devices·2 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
Medical Devices·3 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553
Medical Devices·2 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
Medical Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
Medical Devices·6 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
Medical Devices·2 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
Medical Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
Medical Devices·5 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
Diagnostic Devices·13 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
Diagnostic Devices·50 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
Diagnostic Devices·13 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051
Diagnostic Devices·26 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049
Medical Devices·8 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
Medical Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841
Medical Devices·84 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046
Medical Devices·8 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436
Diagnostic Devices·310 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407
Medical Devices·3 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702
Medical Devices·15 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723
Medical Devices·74 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
Diagnostic Devices·2 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
Medical Devices·1 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438
Diagnostic Devices·34 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
Diagnostic Devices·218 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014
Medical Devices·7 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631
Medical Devices·10 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI
Medical Devices·20 affected·Nov 9, 2022
High RiskFDA
Biomerieux Inc
GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105
Diagnostic Devices·2 affected·Nov 9, 2022