The Recall Desk

Archive

February 2022 recalls

666 recalls were announced in February 2022.

What the numbers show

Critical
14
Severe
237
High
233
Moderate
176
Low
6

Of the 666 recalls this month scored against our rubric, 2% are Critical, 36% are Severe.

Which agencies issued them

401–500 of 666

  • ModerateFDA (Drugs)·D-0511-2022·2022-02-09

    CETAFEN Extra Acetaminophen 500 mg caplets recalled for manufacturing deviations

    Ultra Seal Corporation is recalling CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets in 2-count packets nationwide due to current good manufacturing practice (cGMP) deviations.

    Product
    CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0461-2022·2022-02-09

    Doxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution

    Teva Pharmaceuticals USA is recalling Doxylamine Succinate and Pyridoxine Hydrochloride delayed-release tablets because dissolution test results for the active ingredient fall below specification limits, which may affect drug effectiveness.

    Product
    DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE — DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0514-2022·2022-02-09

    MIRALAC Calcium Carbonate Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling MIRALAC calcium carbonate 420mg tablets in mint flavor due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 409,890 packets distributed nationwide.

    Product
    MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0496-2022·2022-02-09

    Mint Flavored Antacid Recalled for cGMP Manufacturing Deviations

    Ultra Seal Corporation is recalling 1,309,800 packets of Mint Flavored Antacid (Calcium Carbonate 420mg) distributed nationwide due to cGMP deviations. The recall is voluntary and applies to specific lot numbers with expiration dates in 2022.

    Product
    Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0471-2022·2022-02-09

    CYSTEX Urinary Pain Relief tablets recalled for cGMP deviations

    Ultra Seal Corporation is voluntarily recalling CYSTEX Urinary Pain Relief tablets nationwide due to cGMP (current good manufacturing practice) deviations. The recall affects specific lot numbers distributed in 40-count and 20-count blister packages.

    Product
    CYSTEX — CYSTEX (METHENAMINE, SODIUM SALICYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0520-2022·2022-02-09

    Tretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications

    Teva Pharmaceuticals USA is recalling Tretinoin Capsules 10 mg due to failed dissolution specifications and out-of-specification test results. Approximately 1,175 bottles distributed nationwide may not dissolve properly.

    Product
    Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0518-2022·2022-02-09

    Sinus Relief Drug Recall for cGMP Manufacturing Deviations

    Ultra Seal Corporation is recalling Sinus Relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. Affected lots are AK9651 (exp. 06/2022) and AK9437 (exp. 01/2022).

    Product
    Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2022·2022-02-09

    Magnacal Calcium Carbonate Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling MAGNACAL calcium carbonate 420 mg tablets (Lot #AK9768, expiration 08/2022) nationwide due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall was initiated on January 24, 2022.

    Product
    MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0480-2022·2022-02-09

    Cold Relief Drug Recalled for Manufacturing Deviations

    Ultra Seal Corporation is recalling 227,010 packets of Cold Relief Severe Pain/Cough due to cGMP deviations. The recall affects Lot #AK9436 (expiration 01/2022) distributed nationwide.

    Product
    Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0512-2022·2022-02-09

    AYPANAL Pain Reliever Tablets Recalled for Manufacturing Deviations

    Ultra Seal Corporation is recalling AYPANAL Non-aspirin Pain Reliever tablets (acetaminophen 325 mg) in 2-count packets nationwide due to Current Good Manufacturing Practice (cGMP) deviations.

    Product
    AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0498-2022·2022-02-09

    Regular Strength Pain Reliever recalled for cGMP deviations

    Ultra Seal Corporation is recalling approximately 1.18 million packets of Regular Strength Pain Reliever nationwide due to current good manufacturing practice (cGMP) deviations.

    Product
    Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0517-2022·2022-02-09

    REMfresh Melatonin Caplets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling REMfresh Advanced Ion-Powered Melatonin 5 mg caplets nationwide due to cGMP (current good manufacturing practice) deviations. The recall affects approximately 40,344 blisters of the product.

    Product
    REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0510-2022·2022-02-09

    Cough & Cold Drug Recalled for Manufacturing Deviations

    Ultra Seal Corporation is recalling 225,000 packets of CETAFEN Cough & Cold coated tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects Lot #AK9841 with expiration date 10/2022.

    Product
    CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0515-2022·2022-02-09

    Electrolyte Supplement Tablets Recalled for Manufacturing Deviations

    Ultra Seal Corporation is recalling approximately 1.47 million packets of Electrolyte Supplement Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.

    Product
    ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0475-2022·2022-02-09

    Drug recall: MidNite Sleep Health melatonin tablets, cGMP deviations

    Ultra Seal Corporation is voluntarily recalling MidNite Sleep Health melatonin tablets nationwide due to current good manufacturing practice (cGMP) deviations. Approximately 2.2 million bottles are affected.

    Product
    MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0508-2022·2022-02-09

    Nutralox Mint Antacid Chewable Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling 1,486,050 packets of Nutralox Mint Antacid chewable tablets (calcium carbonate 420mg, 2-count packets) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0544-2022·2022-02-09

    Medical device control product pouches mislabeled with incorrect catalog number

    Microbiologics Inc recalls KWIK-STIK IVD control product (lot 323-108-7) containing 47 packs due to pouches being labeled with incorrect catalog number 726-57-10 instead of correct labeling.

    Product
    KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0551-2022·2022-02-09

    Olympus Spiration Valve System mislabeled with incorrect model number

    Olympus Corporation is recalling 35 units of the Spiration Valve System (SVS-V9-00) due to a mislabeled patient charge label indicating model SVS-V7-00 instead. The incorrect label could confuse healthcare providers about which valve was implanted.

    Product
    Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0472-2022·2022-02-09

    DBI 357 Super Magnum Caffeine Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling DBI 357 Super Magnum Quick Energy Stimulant caffeine tablets distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall includes 36-count, 100-count, and 500-count bottles, as well as 3-count packets.

    Product
    DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c) 500-count bottles, and d) 3-count packets, Marketed by: DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN 46
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0476-2022·2022-02-09

    Drug Recall: Back Pain-Off Tablets Over cGMP Violations

    Ultra Seal Corporation is voluntarily recalling Back Pain-Off tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 1.96 million 2-count packets distributed across the United States.

    Product
    Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0469-2022·2022-02-09

    Extra Strength Pain Reliever Acetaminophen Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling Extra Strength Pain Reliever (acetaminophen 500 mg) 2 tablet packets nationwide due to cGMP deviations. The recall affects Lot #AK9602 with expiration date 05/2022.

    Product
    Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·22074·2022-02-09

    Stance Kids Crew Socks Recalled Due to Choking Hazard

    Stance is recalling about 10,800 Kids Reiny Szn Mid-Cushion Crew Socks because bells attached to the socks can detach, posing choking and aspiration hazards to young children.

    Product
    Kids Reiny Szn Mid-Cushion Crew Socks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2022·2022-02-09

    Sinus Decongestant Nasal Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling 448,300 packets of SINUS DECONGESTANT (phenylephrine HCl 5mg) tablets due to current Good Manufacturing Practice (cGMP) deviations. The recall affects nationwide distribution.

    Product
    SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0485-2022·2022-02-09

    Pain Away Pain Reliever/Fever Reducer Drug Recall for cGMP Deviations

    Ultra Seal Corporation is recalling 1,186,000 packets of Pain Away Pain Reliever/Fever Reducer nationwide due to manufacturing practice deviations. The recall was initiated by the firm on a voluntary basis.

    Product
    Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0501-2022·2022-02-09

    PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling PEPTIME Energy 250mg caffeine tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 100-count bottles distributed in the United States.

    Product
    PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0465-2022·2022-02-09

    Cold Tablet with Acetaminophen Recalled for cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant packets due to cGMP (current Good Manufacturing Practice) deviations. Approximately 313,000 packets of Lot #K9824 (Exp. Date 09/2022) distributed nationwide are affected.

    Product
    Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0489-2022·2022-02-09

    SINU-PHEN PLUS Sinus Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling SINU-PHEN PLUS sinus pain and congestion tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects approximately 122,400 packets distributed across the United States.

    Product
    SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0491-2022·2022-02-09

    Extra Strength Un-Aspirin Acetaminophen Packets Recalled for cGMP Deviations

    Ultra Seal Corporation has voluntarily recalled 1,694,200 packets of Extra Strength Un-Aspirin (acetaminophen 500 mg) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0479-2022·2022-02-09

    Lite Remfresh Melatonin Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling Lite Remfresh Advanced Ion-Powered Melatonin 0.5mg tablets nationwide due to cGMP (current good manufacturing practices) deviations. The recall affects 25,776 blisters in lots 19E058A and 19E058B with an expiration date of May 2022.

    Product
    Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0487-2022·2022-02-09

    Cold Terminator decongestant recalled for cGMP deviations

    Ultra Seal Corporation is voluntarily recalling Cold Terminator decongestant/cold relief tablets due to manufacturing compliance deviations. The recall affects 226,400 packets distributed nationwide.

    Product
    COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0516-2022·2022-02-09

    REMfresh Advanced Ion-Powered Melatonin Caplets Recalled for cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling REMfresh Advanced Ion-Powered Melatonin 2 mg Caplets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 12-count and 36-count blister packages distributed across the United States.

    Product
    REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0505-2022·2022-02-09

    CVS Health Natural Sleep Aid Chewable Tablets Recalled for Manufacturing Deviations

    CVS Health Natural Sleep Aid Chewable Tablets (melatonin 1.5mg) in cherry flavor are being recalled nationwide due to cGMP manufacturing deviations. The manufacturer, Ultra Seal Corporation, initiated the voluntary recall of 241,560 bottles.

    Product
    CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0464-2022·2022-02-09

    Nasal & Sinus Decongestant Recalled for cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling Nasal & Sinus Decongestant packets containing phenylephrine HCl 5mg due to current good manufacturing practice (cGMP) deviations. The recall affects 3,508,200 packets distributed nationwide.

    Product
    Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0490-2022·2022-02-09

    DILOTAB II Sinus Cold Relief Drug Recalled for Manufacturing Deviations

    Ultra Seal Corporation is recalling DILOTAB II Sinus and Cold Relief tablets nationwide due to cGMP (current good manufacturing practice) deviations. Approximately 2.7 million packets containing acetaminophen 325 mg and phenylephrine HCl 5 mg are affected.

    Product
    DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0503-2022·2022-02-09

    PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling PEPTIME Energy (caffeine 350mg) tablets due to cGMP (current good manufacturing practice) deviations. The recall affects 113,040 packets and 7,132 bottles distributed nationwide.

    Product
    PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0477-2022·2022-02-09

    Cetafen acetaminophen tablets recalled for manufacturing deviations

    Ultra Seal Corporation is recalling Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets in 2-count packets due to current good manufacturing practice (cGMP) deviations. The recall affects 915,770 packets distributed nationwide.

    Product
    Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0509-2022·2022-02-09

    Drug Recall: FEM-PRIN Menstrual Relief Tablets for cGMP Deviations

    Ultra Seal Corporation is recalling FEM-PRIN Menstrual Relief tablets (223,090 packets) distributed nationwide due to cGMP deviations. The recall was voluntary and initiated on January 24, 2022.

    Product
    FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0468-2022·2022-02-09

    Drug Recall: CHLORESIN Cold and Cough Medication Due to Manufacturing Violations

    Ultra Seal Corporation is voluntarily recalling CHLORESIN, a combination cold and cough medication, due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 225,350 packets distributed nationwide.

    Product
    CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0546-2022·2022-02-09

    Medical Device QC Kit Component Bears Incorrect Expiration Date Label

    Microbiologics Inc is recalling KWIK-STI(TM) GBS QC Set components with a mislabeled expiration date. The Lactobacillus acidophilus component was labeled 7/31/2020 instead of 7/31/2022.

    Product
    KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0481-2022·2022-02-09

    Multi-Symptom Cramp Relief Drug Recalled for Manufacturing Deviations

    Ultra Seal Corporation recalled 1,351,660 packets of Multi-Symptom Cramp Relief nationwide due to current good manufacturing practice (cGMP) deviations. The recall was voluntarily initiated and affects two lots with expiration dates in January and July 2022.

    Product
    Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0631-2022·2022-02-09

    Kirkland Signature Organic Soy Beverage Recalled Due to Spoilage

    Kirkland Signature Organic Soy Non-Dairy Beverage Vanilla from SunOpta is being recalled due to product quality issues. Consumer complaints of spoilage prompted the recall, affecting certain cases distributed in Arizona, California, and Washington.

    Product
    Kirkland Signature Organic Soy Non-Dairy Beverage Vanilla; 12- 32 oz. cartons (note- 12 count consumer display case) SunOpta Item number 1243803 Individual Carton UPC: 0 96619 99861 6; 12 x 32 oz. container carton UPC: 096619 49000 4 Ambient, keep refrigerated after op
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0467-2022·2022-02-09

    Acetaminophen Pain Reliever Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling approximately 1.2 million packets of Maximum Strength Non Aspirin Pain Reliever/Fever Reducer due to current good manufacturing practice (cGMP) deviations. The affected product was distributed nationwide.

    Product
    Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC 67060-210-68
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0507-2022·2022-02-09

    Exaprin Pain Reliever Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling Exaprin pain reliever tablets nationwide due to cGMP (current good manufacturing practices) deviations. The recall affects approximately 1.14 million packets distributed across the United States.

    Product
    Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0558-2022·2022-02-09

    Celltrion DiaTrust COVID-19 Rapid Test Recalled—Unapproved European Version Distributed

    Celltrion USA Inc. is recalling 162,000 units of the European version of its DiaTrust COVID-19 Ag Rapid Test, which was not approved for U.S. distribution. The test packaging and labeling differ from the FDA-approved U.S. version.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0543-2022·2022-02-09

    Microbiologics KWIK-STIK Candida Parapsilosis Control Has Incorrect Pouch Labeling

    Microbiologics is recalling KWIK-STIK Candida parapsilosis diagnostic controls with lot 726-57-10 because some pouches are labeled with incorrect catalog number (323-108-7 instead of 0726P).

    Product
    KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Drugs)·D-0521-2022·2022-02-09

    Mimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall

    Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate) tablets nationwide due to mislabeling on certain cartons. The recall affects 218,174 cartons distributed in the United States.

    Product
    MIMVEY — MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0522-2022·2022-02-09

    Prescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals

    Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate) tablets nationwide due to mislabeling. The recall affects 6,430 cartons distributed throughout the USA.

    Product
    MIMVEY — MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V067000·2022-02-08

    Holiday House Travel Trailers Propane Regulator Failure Risk

    Holiday House is recalling certain 2019–2021 travel trailers equipped with defective Winntec propane regulators that may fail and increase propane pressure, raising fire risk in gas appliances.

    Product
    HOLIDAY HOUSE — HOLIDAY HOUSE 24TB, 27RQ, 18RB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V068000·2022-02-08

    Tiffin motorhomes have improperly secured buss bars increasing fire risk

    Tiffin is recalling 2018-2022 Allegro and Allegro Breeze motorhomes where an improperly secured electrical buss bar can cause the DC Distribution Panel to overheat and potentially start fires. Dealers will replace the buss bar with a cable for free.

    Product
    TIFFIN — TIFFIN ALLEGRO, ALLEGRO BREEZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V065000·2022-02-07

    Roadtrek Recreational Vehicles Recalled for Unattached Propane Lines

    Roadtrek is recalling certain 2021-2022 recreational vehicles because the propane line may not be attached to the water heater. An unattached propane line can allow gas to enter the vehicle, increasing the risk of a fire.

    Product
    ROADTREK — ROADTREK ZION SRT, ZION SLUMBER, ZION, PLAY SLUMBER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V064000·2022-02-07

    Audi Recalls 2022 Q3 Vehicles for Rearview Camera Software Error

    Audi is recalling 2022 Q3 vehicles because a software error may prevent the rearview camera from displaying an image when reversing, increasing crash risk.

    Product
    AUDI — AUDI Q3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V063000·2022-02-04

    Tesla Model Y Boombox Feature May Obscure Pedestrian Warning System

    Tesla is recalling certain 2020-2022 Model Y vehicles because the Boombox feature can obscure the Pedestrian Warning System sounds, creating a collision risk. Tesla will disable the Boombox in Drive, Neutral, and Reverse modes via software update.

    Product
    TESLA — TESLA MODEL 3, MODEL X, MODEL Y, MODEL S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V056000·2022-02-03

    Hyundai Recalls Vehicles Due to ABS Module Fire Risk

    Hyundai is recalling specific 2014-2019 models because a faulty ABS module could cause an electrical short and engine compartment fire.

    Product
    HYUNDAI — HYUNDAI TUCSON, SANTA FE, SANTA FE SPORT, SANTA FE XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V061000·2022-02-03

    Honda Recalls 2021 CBR1000RR-R Fireblade SP Motorcycles for Fire Risk

    Honda is recalling 2021 CBR1000RR-R Fireblade SP motorcycles because an overheating exhaust pipe could melt the oil cooler pipe, causing a leak that increases the risk of fire or crash.

    Product
    HONDA — HONDA CBR1000RR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V058000·2022-02-03

    Altec Recalls 2017-2021 LS60 Aerial Devices Due to Bearing Bolt Risk

    Altec is recalling 2017-2021 LS60 aerial devices because bearing bolt washers may interfere with welds, causing bolts to break and increasing injury risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V057000·2022-02-03

    Highland Ridge RV Recalls 2022 Olympia Models Due to Electrical Grounding Defect

    Highland Ridge RV is recalling 2022 Olympia and Olympia Sport recreational vehicles because the metallic electrical box may not be grounded, posing a risk of electric shock.

    Product
    HIGHLAND RIDGE TT — HIGHLAND RIDGE TT OLYMPIA, OLYMPIA SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22719·2022-02-03

    River Street Five-Drawer Chests Recalled for Tip-Over and Entrapment Hazards

    BFG North Carolina is recalling about 1,380 River Street Five-Drawer Chests sold at Rooms To Go from February 2019 through October 2021. The dressers are unstable if not anchored to the wall, posing tip-over and entrapment hazards that may result in death or serious injuries to children.

    Product
    River Street Five-Drawer Chests
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V059000·2022-02-03

    Class C Motorhomes Recalled for Defective Steering Bolts

    Jayco is recalling certain 2021-2022 Entegra Coach Accolade and Jayco Seneca Class C motorhomes because steering arm and tie rod bolts may fracture, causing loss of steering control. Free replacement available.

    Product
    JAYCO — JAYCO, ENTEGRA SENECA PRESTIGE, ACCOLADE XL, SENECA, ACCOLADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22E006000·2022-02-03

    Nexxpro Recalls X.R2 Motorcycle Helmets Due to Impact Protection Defect

    Nexxpro is recalling specific X.R2 motorcycle helmets because they may not adequately protect the wearer in a crash. Owners will receive free replacements.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0609-2022·2022-02-02

    Twisted Chopped Caesar salad recalled for potential Listeria contamination

    Fresh Express Inc is recalling Twisted Chopped Caesar salad in 9.4oz packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers in 20 U.S. states and Canada.

    Product
    "Twisted Chopped Caesar" (salad product) packed in 9.4oz. packages
    Category
    Food
    Distribution
    20 states
  • CriticalFDA (Food)·F-0548-2022·2022-02-02

    Fresh Express Salad Kits Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Chopped Kit Thai 'N' Cashews salad products due to potential contamination with Listeria monocytogenes. The recall affects 21,053 cases distributed across multiple U.S. states and Canada.

    Product
    "Chopped Kit Thai "N" Cashews" (salad product) packed in 11.7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0493-2022·2022-02-02

    Trilogy Evo Ventilator Recalled for Foam Degradation Risk

    Philips Respironics recalls 473 Trilogy Evo ventilators due to non-conforming foam that may degrade and release particles. Affected patients risk inhaling or ingesting foam particles and chemicals during device use.

    Product
    Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adul
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Food)·F-0552-2022·2022-02-02

    Chopped Sunflower Bacon Salad Recall for Listeria Contamination

    Fresh Express Inc is recalling Chopped Sunflower Bacon salad products (13.8oz and 22.3oz packages) due to potential Listeria monocytogenes contamination. The recall affects domestic and Canadian distributors across multiple states.

    Product
    "Chopped Sunflower Bacon" (salad product) packed in 13.8oz. and 22.3oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0536-2022·2022-02-02

    Caesar Supreme Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Caesar Supreme salad products in 10.5oz packages due to potential contamination with Listeria monocytogenes. The recall affects 41,544 cases distributed to retailers and distributors across multiple states and Canada.

    Product
    "Caesar Supreme" (salad product) packed in 10.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0404-2022·2022-02-02

    Lidocaine HCL / Bupivacaine HCL Sterile Ophthalmic Solution Lacks Sterility Assurance

    Edge Pharma is recalling a sterile ophthalmic injectable solution because the manufacturer cannot guarantee that the product remains sterile. The recall affects approximately 1,202 syringes distributed nationwide.

    Product
    Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0553-2022·2022-02-02

    Fresh Express Chopped Sweet Kale Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling approximately 27,047 cases of Chopped Sweet Kale salad due to potential contamination with Listeria monocytogenes. The affected 10.9oz packages were distributed across multiple states and Canada.

    Product
    "Chopped Sweet Kale" (salad product) packed in 10.9oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0578-2022·2022-02-02

    Organic Chopped Kale Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Organic Chopped Kale in 12oz packages due to potential contamination with Listeria monocytogenes. The affected product was distributed to wholesalers across the US and Canada.

    Product
    "Organic Chopped Kale" (salad product) packed in 12oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0601-2022·2022-02-02

    Fresh Express Spring Mix & Spinach Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling "Spring Mix & Spinach" salad products in 5oz. and 10oz. packages due to potential contamination with Listeria monocytogenes. The recall affects approximately 25,914 cases distributed to multiple U.S. states and Canada.

    Product
    "Spring Mix & Spinach" (salad product) packed in 5oz. and 10oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0450-2022·2022-02-02

    Pioglitazone Tablets Recalled for Superpotent and Failed Specifications

    Aurobindo Pharma USA Inc. is recalling 792 bottles of Pioglitazone 45 mg tablets distributed nationwide due to superpotent tablets and tablets that fail to meet specifications.

    Product
    PIOGLITAZONE — PIOGLITAZONE (PIOGLITAZONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0529-2022·2022-02-02

    Baby Kale Salad Recalled Due to Listeria Contamination Risk

    Fresh Express Inc is recalling Baby Kale salad in 5oz packages due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian distributors.

    Product
    "Baby Kale" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0595-2022·2022-02-02

    Fresh Express Shredded Lettuce Recall Due to Listeria Contamination Risk

    Fresh Express Inc is recalling shredded lettuce products in multiple package sizes due to potential Listeria monocytogenes contamination. The recall affects approximately 211,228 cases distributed across 20 U.S. states and Canada.

    Product
    "Shredded Lettuce" (salad product) packed in 8oz., 14oz., 16oz., and 5lb. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0571-2022·2022-02-02

    Organic Baby Arugula Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Organic Baby Arugula in 5oz. and 16oz. packages due to potential contamination with Listeria monocytogenes. The product was distributed across multiple U.S. states and Canada.

    Product
    "Organic Baby Arugula" (salad product) packed in 5oz. and 16oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0608-2022·2022-02-02

    Fresh Express Twisted Chopped Asian Caesar Salad Recalled for Listeria

    Fresh Express Inc is recalling Twisted Chopped Asian Caesar salad in 9.6oz packages due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian distributors.

    Product
    "Twisted Chopped Asian Caesar" (salad product) packed in 9.6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0494-2022·2022-02-02

    Trilogy Evo Ventilator Repair Kit Recalled for Degrading Foam Material

    Philips Respironics recalled 205 Trilogy Evo ventilator repair kits containing non-conforming foam material that may degrade into particles potentially inhaled or ingested by users. The affected kits were distributed in the US and internationally.

    Product
    Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric t
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Food)·F-0603-2022·2022-02-02

    Fresh Express Sweet Butter Salad Recalled for Listeria Contamination

    Fresh Express Inc is recalling approximately 98,358 cases of "Sweet Butter" salad in 6oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers in 20 U.S. states and Canada.

    Product
    "Sweet Butter" (salad product) packed in 6oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0412-2022·2022-02-02

    MVASI Sterile Ophthalmic Solution Lacks Assured Sterility

    Edge Pharma is recalling MVASI (bevacizumab-awwb) intraocular injection syringes nationwide due to lack of assurance of sterility. The recall affects 199 syringes with code 11-2021-01@2 dated 12/15/2021.

    Product
    MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose: 1.25mg/0.05mL, Single Use Syringe For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1661-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0418-2022·2022-02-02

    Phenylephrine Injection Recall Due to Sterility Assurance Concerns

    Edge Pharma is recalling phenylephrine injection (20 mg/250 mL) because the manufacturer cannot assure the product maintains sterility. The recall affects 3,930 bags distributed nationwide.

    Product
    PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0524-2022·2022-02-02

    American Salad Product Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling American-brand salad products in 11oz. and 24oz. packages due to potential Listeria monocytogenes contamination. Products were distributed across 20 U.S. states and Canada.

    Product
    "American" (salad product) packed in 11oz. and 24oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0550-2022·2022-02-02

    Fresh Express Chopped Southwest Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Chopped Southwest salad in 10.3oz packages due to potential Listeria monocytogenes contamination. The recall affects 40,867 cases distributed to domestic and Canadian distributors.

    Product
    "Chopped Southwest" (salad product) packed in 10.3oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0537-2022·2022-02-02

    Chef Salad Bowl Products Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Chef Salad Bowl products due to potential contamination with Listeria monocytogenes. The recall affects 6.2oz packages distributed to domestic and Canadian distributors.

    Product
    "Chef Salad Bowl" (salad product) packed in 6.2oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0415-2022·2022-02-02

    Edge Pharma Phenylephrine HCl Syringes Recalled for Sterility Assurance

    Edge Pharma, LLC is recalling Phenylephrine HCl 0.5 mg/5mL single-use syringes for intravenous injection nationwide due to lack of assurance of sterility. The affected product was distributed between September 2021 and January 2022.

    Product
    Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0560-2022·2022-02-02

    Green & Crisp Salad Product Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Green & Crisp salad in 11oz packages due to potential Listeria monocytogenes contamination. The recall affects 26,695 cases distributed across multiple US states and Canada.

    Product
    "Green & Crisp" (salad product) packed in 11oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0543-2022·2022-02-02

    Chopped Cherry Almond Gorgonzola Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Chopped Cherry Almond Gorgonzola salad products (13.7 oz packages, codes Z324-Z350) due to potential Listeria monocytogenes contamination. The salad was distributed across 20 U.S. states and Canada.

    Product
    "Chopped Cherry Almond Gorgonzola" (salad product) packed in 13.7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0562-2022·2022-02-02

    Hearts of Romaine Salad Recalled for Listeria Contamination

    Fresh Express Inc is recalling Hearts of Romaine salad in 9oz., 10oz., and 18oz. packages due to potential contamination with Listeria monocytogenes. The affected products were distributed to multiple states and Canada.

    Product
    "Hearts of Romaine" (salad product) packed in 9oz., 10oz., and 18oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0594-2022·2022-02-02

    Santa Fe Bowl salad product recalled for potential Listeria contamination

    Fresh Express Inc is recalling Santa Fe Bowl salad in 5.23oz and 5.7oz packages due to potential Listeria monocytogenes contamination. The product was distributed to over 100 U.S. distributors and Canada.

    Product
    "Santa Fe Bowl" (salad product) packed in 5.23oz. and 5.7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0610-2022·2022-02-02

    Twisted Chopped Greek Caesar Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling Twisted Chopped Greek Caesar salad in 9.3oz packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers in 20 U.S. states and Canada.

    Product
    "Twisted Chopped Greek Caesar" (salad product) packed in 9.3oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0612-2022·2022-02-02

    Fresh Express Veggie Spring Mix Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Veggie Spring Mix salad in 7oz. packages due to potential contamination with Listeria monocytogenes. The product was distributed to multiple states and Canada.

    Product
    "Veggie Spring Mix" (salad product) packed in 7oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0593-2022·2022-02-02

    Romaine Garden Salad Recalled for Potential Listeria Contamination

    Fresh Express Inc is recalling Romaine Garden salad in 12oz. packages due to potential contamination with Listeria monocytogenes. The product was distributed to domestic and Canadian distributors across multiple states.

    Product
    "Romaine Garden" (salad product) packed in 12oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0425-2022·2022-02-02

    Vancomycin HCl Injection Recall for Lack of Sterility Assurance

    Edge Pharma, LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The 1,250 mg/250 mL pre-filled bags were distributed nationwide and may pose a safety risk if used.

    Product
    Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0396-2022·2022-02-02

    Edge Pharma Lidocaine HCl/Epinephrine Injection Lacks Sterility Assurance

    Edge Pharma is recalling approximately 8,140 syringes of Lidocaine HCl/Epinephrine sterile buffered injection solution due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0602-2022·2022-02-02

    Sweet & Crunchy Salad Recalled for Listeria Contamination Risk

    Fresh Express Inc is recalling Sweet & Crunchy salad in 5oz. packages due to potential Listeria monocytogenes contamination. The affected products were distributed to food service distributors across 20 U.S. states and Canada.

    Product
    "Sweet & Crunchy" (salad product) packed in 5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0542-2022·2022-02-02

    Fresh Express Chopped Caesar Salad Recalled for Listeria Risk

    Fresh Express Inc is recalling "Chopped Caesar" salad in 9.4oz., 10.4oz., and 10.5oz. packages due to potential Listeria monocytogenes contamination. The product was distributed to domestic and Canadian distributors.

    Product
    "Chopped Caesar" (salad product) packed in 9.4oz., 10.4oz., and 10.5oz. packages
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-0426-2022·2022-02-02

    Vancomycin HCl Injection Recalled for Sterility Assurance Issues

    Edge Pharma LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The affected product is a 500 mL pre-filled bag for IV injection.

    Product
    Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0622-2022·2022-02-02

    NutriCrafters MCT Powder Recalled Due to Supplier Recall

    NutriCrafters LLC is recalling Nutricrafters MCT Instant Coconut Milk Mixer (1 lb. bottles) because the medium chain triglyceride powder was repacked and distributed from a supplier product that is itself under recall.

    Product
    Nutricrafters MCT - Instant coconut milk mixer; 1 lb. (454 grams) Ingredients: Medium chain triglycerides, tapioca starch. Allergy information : contains oils from tree nuts (coconut) Suggested use: Stir into drinks or spoon over foods. Start with 1 teaspoon, preferably w
    Category
    Food
    Distribution
    0 states

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