FDA recalls, July 2018: 158 published

64 different companies appear this month.

Risk classification: Class I: 44 · Class II: 104 · Class III: 10

Same month, other agencies:CPSC 12 recallsFSIS 6 recallsNHTSA 60 recalls

Recalls this month

DateProduct
July 25, 2018NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single d…D-0959-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S,…Z-2447-2018NewDeal SA
July 25, 2018ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per…D-0964-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 10…D-0937-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged i…D-0921-2018La Vita Compounding Pharmacy, LLC
July 25, 2018PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Vol…D-0965-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syr…D-0933-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mmZ-2435-2018Edwards Lifesciences, LLC
July 25, 2018HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., …D-0934-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018Odwalla Superfood fruit smoothie 15.2 oz. (450mL) plastic bottle; Sold in 8 pack case …F-1656-2018The Coca-Cola Company
July 25, 2018Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 3…D-0955-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 …D-0952-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (US…D-0961-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm…Z-2487-2018Cardinal Health 200, LLC
July 25, 2018Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGI…Z-2503-2018COVIDIEN MEDTRONIC
July 25, 2018PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031Z-2448-2018Ethicon, Inc.
July 25, 2018HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj.,…D-0947-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF…D-0946-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). V…D-0943-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref ASU1200, pack…Z-2490-2018Cardinal Health 200, LLC
July 25, 2018PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: …D-0940-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL…D-0935-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 …D-0951-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, …D-0948-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL.…D-0929-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018TR Toppers Brand Chopped Chocolate Pretzel Pieces. Item number B160-075 GTIN 0 06 51844 1…F-1651-2018T R Toppers, Inc.
July 25, 20180.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). V…D-0942-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30 mL…D-0949-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag.…D-0931-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL an…D-0922-2018La Vita Compounding Pharmacy, LLC
July 25, 2018fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL)…D-0945-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume …D-0953-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 …D-0936-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45…D-0920-2018The Hain Celestial Group, Inc. - Worldwide HQ
July 25, 2018MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volum…D-0954-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial…D-0923-2018La Vita Compounding Pharmacy, LLC
July 25, 2018Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (…Z-2431-2018Medtronic Neuromodulation
July 25, 2018MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volu…D-0938-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref ASU1210, pack…Z-2492-2018Cardinal Health 200, LLC
July 25, 2018Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211, pack…Z-2493-2018Cardinal Health 200, LLC
July 25, 2018fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF, U…D-0944-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volu…D-0956-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP)…D-0939-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252…D-0962-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose…D-0963-2018Avella of Deer Valley, Inc. Store 38
July 25, 2018NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. …D-0958-2018Avella of Deer Valley, Inc. Store 38
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Green Dragon, 1oz, 250g, 1kg packages, Gaia Ethn…D-0996-2018Gaia Ethnobotanical LLC
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Green MD, 1oz, 250g, 1kg packages, Gaia Ethnobot…D-1000-2018Gaia Ethnobotanical LLC
July 18, 2018Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray SystemsZ-2387-2018GE Medical Systems, SCS
July 18, 2018Gaia Kratom (mitragyna speciosa) powder, Red Dragon, 1oz, 250g, 1kg packages, Gaia Ethnob…D-1007-2018Gaia Ethnobotanical LLC

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