FDA recalls, October 2019: 202 published

76 different companies appear this month.

Risk classification: Class I: 68 · Class II: 127 · Class III: 7

Same month, other agencies:CPSC 18 recallsFSIS 4 recallsNHTSA 103 recalls

Recalls this month

DateProduct
October 9, 2019Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of …D-0114-2020KRS Global Biotechnology, Inc
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.0, .070", REF SA6SL40. for cardiovascular useZ-2631-2019Medtronic Vascular
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0, .070", REF SA6JR60. for cardiovascular useZ-2715-2019Medtronic Vascular
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0 SH, .070", REF SA6CHAMP20SH. for cardiov…Z-2701-2019Medtronic Vascular
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0 SH, .070", REF SA6JL40SH. for cardiovascula…Z-2664-2019Medtronic Vascular
October 9, 2019Valencia Sopaipilla Mix, 5 lbs. and 2 lbs., packaged in Paper bags with polyliners. UPC …F-0015-2020Valencia Flour Mill, Ltd.
October 9, 2019Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Gl…D-0059-2020KRS Global Biotechnology, Inc
October 9, 2019Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, R…D-0124-2020Torrent Pharma Inc.
October 9, 2019Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10…D-0116-2020KRS Global Biotechnology, Inc
October 9, 2019Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthal…D-0084-2020KRS Global Biotechnology, Inc
October 9, 2019fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in…D-0049-2020KRS Global Biotechnology, Inc
October 9, 2019C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syrin…D-0018-2020Colonia Care Pharmacy
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular u…Z-2742-2019Medtronic Vascular
October 9, 2019C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515…D-0006-2020Colonia Care Pharmacy
October 9, 2019Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park…D-0042-2020KRS Global Biotechnology, Inc
October 9, 2019C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial, Rx only, C…D-0024-2020Colonia Care Pharmacy
October 9, 2019C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave.…D-0034-2020Colonia Care Pharmacy
October 9, 2019TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464Z-0033-2020Quality Electrodynamics LLC
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F SL5.0, .070", REF SA6SL50. for cardiovascular useZ-2681-2019Medtronic Vascular
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for cardiovascula…Z-2661-2019Medtronic Vascular
October 9, 2019Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fil…D-0101-2020KRS Global Biotechnology, Inc
October 9, 2019Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10…D-0108-2020KRS Global Biotechnology, Inc
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0 SH, .070", REF SA6EBU40SH. for cardiovascu…Z-2629-2019Medtronic Vascular
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070", REF SA6AL30. for cardiovascular useZ-2679-2019Medtronic Vascular
October 9, 2019Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biote…D-0100-2020KRS Global Biotechnology, Inc
October 9, 2019fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill i…D-0050-2020KRS Global Biotechnology, Inc
October 9, 2019C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 In…D-0020-2020Colonia Care Pharmacy
October 9, 2019NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), R…D-0080-2020KRS Global Biotechnology, Inc
October 9, 2019Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill…D-0115-2020KRS Global Biotechnology, Inc
October 9, 2019Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotec…D-0061-2020KRS Global Biotechnology, Inc
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. for cardiovascul…Z-2567-2019Medtronic Vascular
October 9, 2019Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only…D-0118-2020KRS Global Biotechnology, Inc
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, .070", REF SA6ERADL. for cardiovascula…Z-2627-2019Medtronic Vascular
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070", REF SA6SL45. for cardiovascular useZ-2690-2019Medtronic Vascular
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F LARA, .070", REF SA6LARA. for cardiovascular useZ-2688-2019Medtronic Vascular
October 9, 2019C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia C…D-0015-2020Colonia Care Pharmacy
October 9, 2019Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315Z-0013-2020Inter-Med Llc
October 9, 2019C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 N…Z-0024-2020Stryker Instruments Div. of Stryker Corporation
October 9, 2019Fudge Brownie Cookie, net wt. 2 oz. The product was distributed frozen and has a 5-day s…F-2258-2019Whole Flower Farms LLC
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5 SH, .070", REF SA6EBU35SH. for cardiovascu…Z-2626-2019Medtronic Vascular
October 9, 2019OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Singl…D-0083-2020KRS Global Biotechnology, Inc
October 9, 2019NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syri…D-0078-2020KRS Global Biotechnology, Inc
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5, .070" REF SA6SR35. for cardiovascular useZ-2613-2019Medtronic Vascular
October 9, 2019Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities…Z-0028-2020Voco GmbH
October 9, 2019SE Grocers **BAKERY** 18 CT Variety Pack CookiesF-0019-2020SOUTHEASTERN GROCERS - MARKETI
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.0, .070", REF SA6SL30. for cardiovascular useZ-2746-2019Medtronic Vascular
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5 SH, .070" REF SA6SR35SH. for cardiovascular…Z-2614-2019Medtronic Vascular
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL SH, .070", REF SA6ELGAMALSH. for cardiov…Z-2699-2019Medtronic Vascular
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC 3.5, .070", REF SA6MAC35. for cardiovascular …Z-2675-2019Medtronic Vascular
October 9, 2019LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BS…D-0067-2020KRS Global Biotechnology, Inc

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