The Recall Desk

Archive

June 2019 recalls

686 recalls were announced in June 2019.

What the numbers show

Critical
12
Severe
191
High
347
Moderate
123
Low
13

Of the 686 recalls this month scored against our rubric, 2% are Critical, 28% are Severe.

Which agencies issued them

201–300 of 686

  • SevereFDA (Drugs)·D-1372-2019·2019-06-19

    Torrent Pharma Recalls Lactulose Solution Due to Potential Bacterial Contamination

    Torrent Pharma Inc. is recalling 96,060 bottles of Lactulose Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz., NDC: 13668-580-12, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1324-2019·2019-06-19

    Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials for Sterility Concerns

    Pharm D Solutions is recalling Human Chorionic Gonadotropin 10,000 IU vials due to a lack of sterility assurance. The recall affects 26 vials distributed nationwide.

    Product
    Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1355-2019·2019-06-19

    Torrent Pharma Recalls Robafen DM Cough Syrup Due to Bacterial Contamination

    Torrent Pharma Inc is recalling Robafen DM Cough Sugar-Free Clear Cough Expectorant due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP 200 mg in each 2 teaspoonfuls (10mL)), 4 Fl. oz. (118 mL) bottle, NDC: 0904-6306-20, Distributed by Major Pharmaceuticals, Livonia MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1405-2019·2019-06-19

    Synthetopes Recalls Sn-Tetrofosmin Kits Due to Processing Control Deficiencies

    Synthetopes Inc is recalling Sn-Tetrofosmin Kits nationwide due to a lack of processing controls. All lots remaining within their expiry date are affected.

    Product
    Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1369-2019·2019-06-19

    Torrent Pharma Recalls Extra Action Cough Syrup Due to Bacterial Contamination

    Torrent Pharma Inc is recalling Extra Action Cough Syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0970-97, b) One Pint (473 mL) bottle, 0536-0970-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1338-2019·2019-06-19

    Pharm D Solutions Recalls Testosterone Cypionate Vials for Sterility Concerns

    Pharm D Solutions is recalling specific lots of Testosterone Cypionate 200 mg/mL vials due to a lack of sterility assurance.

    Product
    Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1326-2019·2019-06-19

    Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials for Sterility Concerns

    Pharm D Solutions is recalling 104 vials of Human Chorionic Gonadotropin 12,000 IU due to a lack of sterility assurance.

    Product
    Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1353-2019·2019-06-19

    Torrent Pharma Recalls Pseudoephedrine Oral Solution Due to Potential Bacterial Contamination

    Torrent Pharma Inc is recalling Pseudoephedrine Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant, One Pint (473 mL) bottle, NDC: 0536-1850-85, Distributed by Rugby Laboratories, Livonia MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1327-2019·2019-06-19

    FDA Recalls Ipamorelin Acetate Injectable Vials Due to Sterility Concerns

    Pharm D Solutions is recalling 11 vials of Ipamorelin Acetate 9 mg/9mL Injectable due to a lack of sterility assurance.

    Product
    Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1380-2019·2019-06-19

    Torrent Pharma Recalls Cetirizine Hydrochloride Oral Solution Due to Contamination Risk

    Torrent Pharma Inc. is recalling specific lots of Cetirizine Hydrochloride Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1323-2019·2019-06-19

    Pharm D Solutions Recalls B-Complex Injectable Vials Due to Sterility Concerns

    Pharm D Solutions, LLC is recalling specific lots of B-complex injectable vials due to a lack of sterility assurance. The affected product is distributed nationwide.

    Product
    B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1611-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1333-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin Vials Due to Sterility Concerns

    Pharm D Solutions is recalling 100 vials of Sermorelin/GHRP-2 & 6 due to a lack of sterility assurance. The products were distributed nationwide in the United States.

    Product
    Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1337-2019·2019-06-19

    Pharm D Solutions Recalls Testosterone Cyp/Pro Vials for Sterility Concerns

    Pharm D Solutions is recalling 371 vials of Testosterone Cyp/Pro 95/5% due to a lack of sterility assurance. The affected prescription medication was distributed nationwide.

    Product
    Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1381-2019·2019-06-19

    Torrent Pharma Recalls Cetirizine Hydrochloride Oral Solution Due to Contamination

    Torrent Pharma Inc. is recalling specific lots of Cetirizine Hydrochloride Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1334-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin/GHRP-2 &6 Vials for Sterility Concerns

    Pharm D Solutions, LLC is recalling Sermorelin/GHRP-2 &6 vials due to a lack of sterility assurance. The recall affects products distributed nationwide in the United States.

    Product
    Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1347-2019·2019-06-19

    Torrent Pharma Recalls Allergy Liquid Antihistamine Due to Bacterial Contamination

    Torrent Pharma Inc. is recalling 118,080 bottles of Allergy Liquid Antihistamine due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 4 FL. oz. (118 mL) bottle, NDC: 59741-119-06, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Assured.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1376-2019·2019-06-19

    Torrent Pharma Recalls Hydrocortisone Acetate Suppositories Due to Contamination Risk

    Torrent Pharma Inc. is recalling Hydrocortisone Acetate Suppositories due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton, NDC: 59741-301-12, b) 24 Adult Suppositories per carton, NDC: 59741-301-24, Manufactured by Bio-Pharm Inc., Levittown PA 19057.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1384-2019·2019-06-19

    Torrent Pharma Recalls Hydrocodone and Homatropine Oral Solution Due to Contamination

    Torrent Pharma Inc. is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1371-2019·2019-06-19

    Torrent Pharma Recalls Nasal Decongestant Liquid Due to Bacterial Contamination

    Torrent Pharma Inc is recalling specific lots of Nasal Decongestant Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118 mL) bottle, NDC:0536-1850-97, Distributed by Rugby Laboratories, Livonia MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1382-2019·2019-06-19

    Torrent Pharma Recalls Risperidone Oral Solution Due to Bacterial Contamination

    Torrent Pharma Inc. is recalling Risperidone Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1370-2019·2019-06-19

    Torrent Pharma Recalls Diphenhydramine Oral Solution Due to Bacterial Contamination

    Torrent Pharma Inc is recalling Diphenhist Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) bottle., NDC: 0536-0770-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1403-2019·2019-06-19

    Synthetopes Recalls Sn-d, l-Exametazime Due to Lack of Processing Controls

    Synthetopes Inc is recalling Sn-d, l-Exametazime vials nationwide due to a lack of processing controls. The FDA classifies this as a Class II recall.

    Product
    Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1374-2019·2019-06-19

    Torrent Pharma Recalls Memantine Hydrochloride Oral Solution Due to Contamination

    Torrent Pharma Inc is recalling 5,681 bottles of Memantine Hydrochloride Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1362-2019·2019-06-19

    Torrent Pharma Recalls Acetic Acid Otic Solution Due to Bacterial Contamination

    Torrent Pharma is recalling specific lots of Acetic Acid Otic Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1349-2019·2019-06-19

    Torrent Pharma Recalls Robafen Cough Formula Due to Potential Bacterial Contamination

    Torrent Pharma is recalling Robafen Cough Formula Expectorant due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-0061-00, b) One Pint ( 473 mL) bottle, NDC: 0904-0061-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1360-2019·2019-06-19

    Torrent Pharma Recalls Hyoscyamine Sulfate Elixir Due to Bacterial Contamination Risk

    Torrent Pharma is recalling Hyoscyamine Sulfate Elixir due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1354-2019·2019-06-19

    Torrent Pharma Recalls Nasal Decongestant Spray Due to Potential Bacterial Contamination

    Torrent Pharma is recalling specific lots of Nasal Decongestant Spray Regular due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL) bottle, NDC:0904-5711-35, b) 1 FL. oz. (30 mL) bottle, NDC: 0904-5711-30, Distributed by Major Pharmaceuticals, Livonia MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1331-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin/GHRP-2 Vials Due to Sterility Concerns

    Pharm D Solutions, LLC is recalling Sermorelin/GHRP-2 9 mg/9 mg vials because they may lack sterility assurance. The recall covers 6 vials distributed nationwide.

    Product
    Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1358-2019·2019-06-19

    Torrent Pharma Recalls Cyproheptadine Syrup Due to Bacterial Contamination Risk

    Torrent Pharma is recalling Cyproheptadine Hydrochloride Syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin Pharma, Skokie, IL 60076.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1345-2019·2019-06-19

    Torrent Pharma Recalls Risperidone Oral Solution Due to Bacterial Contamination

    Torrent Pharma Inc. is recalling Risperidone Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1377-2019·2019-06-19

    Torrent Pharma Recalls Laxative Suppositories Due to Potential Bacterial Contamination

    Torrent Pharma Inc is recalling Laxative Suppositories (Bisacodyl USP, 10 mg) due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC: 0536-1355-12, b) 100 Suppositories per carton, NDC: 0536-1355-01, Distributed Rugby Laboratories, Livonia, MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1328-2019·2019-06-19

    Pharm D Solutions Recalls Lipo MIC-12 Injectable Vials for Sterility Concerns

    Pharm D Solutions, LLC is recalling 669 vials of Lipo MIC-12 injectable solution due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1322-2019·2019-06-19

    Pharm D Solutions Recalls Bacteriostatic Water for Injection Vials

    Pharm D Solutions, LLC is recalling 716 vials of Bacteriostatic Water for Injection due to a lack of sterility assurance.

    Product
    Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1379-2019·2019-06-19

    Torrent Pharma Recalls Anu-Med Hemorrhoidal Suppositories Due to Bacterial Contamination

    Torrent Pharma is recalling Anu-Med Hemorrhoidal Suppositories due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1383-2019·2019-06-19

    Torrent Pharma Recalls Hydrocodone Oral Solution Due to Bacterial Contamination

    Torrent Pharma Inc. is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA.
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·19V471000·2019-06-19

    Blue Bird Recalls 2018-2019 Electric School Buses for Software Defect

    Blue Bird is recalling 2018-2019 Vision and All American electric school buses because a software defect may cause the vehicle to lose drive and power steering.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1368-2019·2019-06-19

    Torrent Pharma Recalls Cough Syrup Due to Potential Bacterial Contamination

    Torrent Pharma Inc is recalling 249,744 bottles of Guaifenesin Syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle, NDC: 0536-0825-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1373-2019·2019-06-19

    Torrent Pharma Recalls Lactulose Solution Due to Potential Bacterial Contamination

    Torrent Pharma Inc. is recalling specific lots of Lactulose Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, Manufactured By Bio-Pharm, Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1359-2019·2019-06-19

    Torrent Pharma Recalls Hyoscyamine Oral Drops Due to Bacterial Contamination Risk

    Torrent Pharma is recalling Hyoscyamine Oral Drops due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Skokie IL 60076.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1357-2019·2019-06-19

    Biscolax Laxative Suppositories Recalled for Potential Bacterial Contamination

    Torrent Pharma is recalling Biscolax Laxative suppositories due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC: 0904-5058-12, b) 100 suppositories per carton, NDC: 0904-5058-60, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1335-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin Vials Due to Sterility Concerns

    Pharm D Solutions, LLC is recalling Sermorelin/GHRP-2 &6 vials nationwide because the product lacks sterility assurance.

    Product
    Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1356-2019·2019-06-19

    Torrent Pharma Recalls Pedia Relief Cough-Cold Oral Solution Due to Contamination

    Torrent Pharma Inc is recalling Pedia Relief Cough-Cold Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant, nasal decongestant, Chlorpheniramine Maleate, USP 2 mg; Dextromethorphan HBr, USP 10 mg; Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10 mL)), 4 Fl. oz. (118 mL) bottle, NDC:0904-5050-20, Dist
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1330-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin/Ipamorelin Vials Due to Sterility Concerns

    Pharm D Solutions is recalling Sermorelin/Ipamorelin 18 mg/15 mg vials because they lack sterility assurance. The recall covers 24 vials distributed nationwide.

    Product
    Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1329-2019·2019-06-19

    Pharm D Solutions Recalls Nandrolone Decanoate Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Nandrolone Decanoate 200 mg/mL injectable vials due to a lack of sterility assurance. The recall covers 50 vials distributed nationwide.

    Product
    Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1348-2019·2019-06-19

    Torrent Pharma Recalls Children's Mapap Acetaminophen Liquid Due to Contamination

    Torrent Pharma is recalling Children's Mapap Acetaminophen Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen 160 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC 0904-1985-20, b) One Pint (473 mL) bottle, NDC: 0904-1985-16, Distributed by Major Pharmaceuticals, L
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1364-2019·2019-06-19

    Torrent Pharma Recalls Guaifenesin DAC Oral Solution Due to Contamination

    Torrent Pharma Inc. is recalling specific lots of Guaifenesin DAC Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongestant, Cough Suppressant, 100 mg/30 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-301-16, Manufactured by Bio-Pharm Inc., L
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1346-2019·2019-06-19

    Torrent Pharma Recalls Children's Acetaminophen Liquid Due to Potential Bacterial Contamination

    Torrent Pharma Inc is recalling 58,272 bottles of Children's Acetaminophen Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL) bottle, NDC: 59741-101-06, Manufactured by Bio-Pharm, Inc., Levittown PA 19057, Assured.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1378-2019·2019-06-19

    Torrent Pharma Recalls Hemorrhoidal Suppositories Due to Bacterial Contamination

    Torrent Pharma is recalling 82,872 bottles of Hemorrhoidal Suppositories due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA.
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Food)·F-1457-2019·2019-06-19

    Park Street Deli Hummus Recalled for Undeclared Peanut Butter

    Del Monte Fresh Produce is recalling Park Street Deli Classic Hummus with Carrots & Celery due to undeclared peanut butter.

    Product
    Park Street Deli, Hummus and Veggies, Classic Hummus, Carrots & Celery NET WT 5 OZ (142g)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1453-2019·2019-06-19

    Meiji Chocolate Kinoko No Yama Recalled for Missing English Allergen Labels

    Wismettac Asian Foods is recalling Meiji Chocolate Kinoko No Yama bars because they lack English labels for ingredients and allergens.

    Product
    CHOCOLATE KINOKO NO YAMA MEIJI, 2.61 oz. Item number 65879 UPC 074410658793 - only on those bars with English labeling. Distributed by Wismettac Asian Foods, Inc.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1447-2019·2019-06-19

    Izzio Artisan Bakery 100% Rye Bread Recalled for Undeclared Wheat

    Izzio Artisan Bakery is recalling 100% Rye Bread because it may contain undeclared wheat. The product was distributed nationwide.

    Product
    Izzio Artisan Bakery 100% Rye Bread, Net Weight: 9 oz ; 8 slices per package, Flow Wrap Package. Frozen. Item #3301, Case UPC #657082033015, Unit UPC #657082033015
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1452-2019·2019-06-19

    Meiji Chocolate Macadamia Bars Recalled for Missing English Allergen Labels

    Wismettac Asian Foods is recalling Meiji Chocolate Macadamia bars because they lack English labels for nutrition facts, ingredients, and allergens.

    Product
    CHOCOLATE MACADAMIA MEIJI, 2.25 oz. Item number 69920 UPC 074410699208 - only on those bars with English labeling. Distributed by Wismettac Asian Foods, Inc.
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·19V473000·2019-06-19

    Audi Recalls 2019 Q5 and SQ5 Models for Air Bag Defect

    Volkswagen Group of America is recalling 2019 Audi Q5 and SQ5 vehicles because a defective instrument panel carrier may damage the passenger air bag during a crash.

    Product
    AUDI — AUDI Q5, SQ5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V474000·2019-06-19

    Audi Recalls Vehicles Due to Passenger Air Bag Deactivation Risk

    Audi is recalling specific 2015-2019 models because an electrical issue may cause the passenger air bag to deactivate, increasing injury risk in a crash.

    Product
    AUDI — AUDI A3 CABRIOLET, RS 3, A3 SPORTBACK E-TRON, S3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1445-2019·2019-06-19

    Cool Haus Dairy-Free Horchata Frozen Dessert Recalled for Undeclared Milk

    Cool Haus is recalling its Dairy-Free Horchata Frozen Dessert Sandwich because it contains undeclared milk, a major allergen.

    Product
    Cool Haus Awesome Dessert - Dairy Free Horchata Frozen Dessert Sandwich. Horchata Rice Milk & Cinnamon frozen dessert with Snickerdoodle Cookies 5.8 fl. oz. in film wrapper. 10 individual items per case. UPC: 851916003650 Product number: CoolV004 Ingredients: Snickerdoodle
    Category
    Food
    Distribution
    12 states
  • HighNHTSA·19E041000·2019-06-19

    Gillig Recalls Transpec T287X Series Glass Roof Hatches for Shattering Risk

    Gillig LLC is recalling Transpec T287X Series glass roof hatches sold as aftermarket parts because temperature and vibration stresses may cause the tempered glass to shatter, potentially injuring passengers.

    Product
    STRUCTURE:EMERGENCY:ESCAPE/EGRESS/EXIT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2019·2019-06-19

    Getinge 86-Series Medical Washer-Disinfector Recalled for Potential Hose Collapse

    Maquet Cardiovascular is recalling four Getinge 86-Series Medical Washer-Disinfector units because the inlet pump hose may collapse, potentially preventing proper cleaning of medical instruments.

    Product
    Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1755-2019·2019-06-19

    GE Healthcare Recalls Silhouette VR Systems Due to Monitor Mount Failure

    GE Healthcare is recalling 825 Silhouette VR systems because a CRT monitor fell off its wall mount due to product aging.

    Product
    Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1775-2019·2019-06-19

    Conformis iTotal Hip Replacement System Recalled for Dimensional Discrepancy

    Conformis, Inc. is recalling 128 iTotal Hip Replacement System stems due to a 3mm discrepancy between approved and manufactured neck/head lengths.

    Product
    Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1454-2019·2019-06-19

    Meiji Chocolate Wheat Snack Recalled for Missing English Allergen Labels

    Wismettac Asian Foods is recalling Meiji Chocolate Takenoko no Sato bars because they lack English labels for ingredients and allergens, including milk, soy, egg, and tree nuts.

    Product
    CHOCOLATE TAKENOKO NO SATO MEIJI (Chocolate wheat snack, 2.46 oz. Item number 65880 UPC 074410658809 - only on those bars with English labeling. Distributed by Wismettac Asian Foods, Inc.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1780-2019·2019-06-19

    Cook Inc. Recalls Neff Percutaneous Access Sets Due to Sterility Concerns

    Cook Inc. is recalling 97 Neff Percutaneous Access Sets because they may have been manufactured without a bottom seal, compromising sterility. No US distribution occurred.

    Product
    Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1752-2019·2019-06-19

    GE Healthcare Recalls Proteus XR/a Radiographic Systems Due to Monitor Fall Risk

    GE Healthcare is recalling 825 Proteus XR/a radiographic systems because a monitor fell off its wall mount due to product aging.

    Product
    Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2019·2019-06-19

    Getinge 86-Series Medical Washer-Disinfector Recalled for Potential Hose Collapse

    Maquet Cardiovascular is recalling 40 Getinge 86-Series Medical Washer-Disinfector units because the inlet pump hose may collapse, potentially preventing proper cleaning of medical instruments.

    Product
    Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1769-2019·2019-06-19

    Terumo Electronic Patient Gas System Recalled for Control Slider Failure

    Terumo is recalling 72 Electronic Patient Gas Systems used in cardio-pulmonary bypass because a fault disables control sliders, forcing use of local knobs.

    Product
    Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1753-2019·2019-06-19

    GE Healthcare Recalls Prestilix 1600X Digital Radiology Systems

    GE Healthcare is recalling 825 Prestilix 1600X digital radiology systems because a monitor fell off its wall mount due to product aging.

    Product
    Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2019·2019-06-19

    Medtronic InterStim System Recall for Unexpected Stimulation Increase

    Medtronic is recalling InterStim System kits due to a potential for unexpected stimulation increases during programming with the A10 Clinician Application.

    Product
    InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1352-2019·2019-06-19

    Torrent Pharma Recalls Banophen Oral Solution Due to Bacterial Contamination Risk

    Torrent Pharma Inc is recalling Banophen Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful contains diphenhydramine hydrochloride, USP 12.5 mg, a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-1228-00, b) One Pint (473 mL) bottle, NDC: 0904-5174-16, Distributed by Major
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1779-2019·2019-06-19

    Skytron Integrity 270 Steam Sterilizer Recalled for Weld Fatigue

    Skytron is recalling five Integrity 270 Steam Sterilizers because the weld attaching the air heater assembly has shown signs of fatigue or failure.

    Product
    Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1781-2019·2019-06-19

    GE Centricity PACS-IW Recall for Potential Missing Image Series

    GE Healthcare is recalling 620 units of Centricity PACS-IW software because image series may be missing from exams without a warning.

    Product
    GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1449-2019·2019-06-19

    Meiji Chocolate Milk Chocolate Bars Recalled for Missing English Allergen Labels

    Wismettac Asian Foods is recalling Meiji Chocolate Milk Chocolate bars because they lack English labels for ingredients and allergens, including milk, soy, egg, and tree nuts.

    Product
    CHOCOLATE MILK CHOCOLATE MEIJI, 1.75 oz. Item number 70378 UPC 074410703783 - only on those bars with English labeling. Distributed by Wismettac Asian Foods, Inc.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1450-2019·2019-06-19

    Meiji Black Chocolate Recalled for Missing English Allergen Labels

    Wismettac Asian Foods is recalling Meiji Black Chocolate bars because they lack English labels for nutrition facts, ingredients, and allergens.

    Product
    CHOCOLATE BLACK CHOCOLATE MEIJI, 1.75 oz. Item number 69341 UPC 074410693411 - only on those bars with English labeling. Distributed by Wismettac Asian Foods, Inc.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1451-2019·2019-06-19

    Meiji Chocolate Almond Bars Recalled for Missing English Allergen Labels

    Wismettac Asian Foods is recalling Meiji Chocolate Almond bars because they lack English labels for ingredients and allergens, including milk, soy, egg, and tree nuts.

    Product
    CHOCOLATE ALMOND CHOCOLATE MEIJI, 3.1 oz. Item number 64344 UPC 074410643447 - only on those bars with English labeling. Distributed by Wismettac Asian Foods, Inc.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1402-2019·2019-06-19

    Synthetopes Recalls Sulfur Colloid Reaction Vials Due to Processing Controls

    Synthetopes Inc. is recalling Sulfur Colloid Reaction Vials nationwide due to a lack of processing controls.

    Product
    Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1773-2019·2019-06-19

    CardioCommand Transesophageal Cardiac Pacing System Recalled for Battery Corrosion

    Cardiocommand Inc. is recalling five units of its Transesophageal Cardiac Pacing and Recording System, Model 7A, due to possible corrosion of the battery contacts.

    Product
    CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1772-2019·2019-06-19

    Philips IntelliBridge System Recall for Infusion Pump Data Storage Accuracy Issues

    Philips is recalling IntelliBridge Systems configured with comma decimal separators because infusion pump data may be recorded at 100 times the actual values.

    Product
    Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 IntelliBridge System C.01 (or later) 866418 IntelliBridge System C.01 upgrade (or later) Product Usage: The IntelliBridge System is indicated for use in data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1754-2019·2019-06-19

    GE Healthcare Precision 500D X-ray System Recall for Monitor Mount Failure

    GE Healthcare is recalling Precision 500D X-ray systems because a CRT monitor fell off its wall mount due to product aging.

    Product
    Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1401-2019·2019-06-19

    Synthetopes Recalls Sn-Mertiatide Kit Due to Processing Control Deficiencies

    Synthetopes Inc is recalling Sn-Mertiatide Kits nationwide due to a lack of processing controls. The recall covers all lots remaining within their expiry date.

    Product
    Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1404-2019·2019-06-19

    Synthetopes Recalls Sn-DTPA Kit Due to Lack of Processing Controls

    Synthetopes Inc is recalling 82 vials of Sn-DTPA Kit 10 mg nationwide due to a lack of processing controls.

    Product
    Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1340-2019·2019-06-19

    Glenmark Recalls Estradiol Vaginal Inserts Due to Defective Plunger

    Glenmark Pharmaceuticals is recalling Estradiol Vaginal Inserts because the plunger delivery system is not functioning properly.

    Product
    ESTRADIOL VAGINAL INSERTS — ESTRADIOL VAGINAL INSERTS (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1771-2019·2019-06-19

    Philips Patient Information Center iX Recall for Infusion Pump Data Accuracy

    Philips is recalling Patient Information Center iX software because infusion pump data may be recorded at 100 times the actual rate.

    Product
    Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1776-2019·2019-06-19

    Conformis iTotal Hip Replacement System Recalled for Dimensional Discrepancy

    Conformis is recalling 183 iTotal Hip Replacement System stems nationwide due to a 3mm discrepancy between approved and manufactured neck/head lengths.

    Product
    Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1767-2019·2019-06-19

    Luminex xTAG Gastrointestinal Pathogen Panel Recalled for Lower MS2 MFI Values

    Luminex Molecular Diagnostics is recalling 965 xTAG Gastrointestinal Pathogen Panel kits due to reports of lower MS2 MFI values.

    Product
    xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Drugs)·D-1399-2019·2019-06-19

    Synthetopes Recalls Pentreotide Vials Due to Lack of Processing Controls

    Synthetopes Inc. is recalling Pentreotide (10 uGm) vials nationwide due to a lack of processing controls. All lots remaining within expiry are affected.

    Product
    Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1400-2019·2019-06-19

    Synthetopes Recalls Sn-DMSA Solution Due to Processing Control Deficiencies

    Synthetopes Inc. is recalling Sn-DMSA solution vials nationwide due to a lack of processing controls. The product is not for direct injection.

    Product
    Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1341-2019·2019-06-19

    Chiesi Recalls ZYFLO CR Tablets Due to Dissolution Failure

    Chiesi USA is recalling ZYFLO CR (zileuton) extended-release tablets because they failed to meet dissolution specifications. The recall affects 2,118 bottles distributed nationwide.

    Product
    ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1436-2019·2019-06-19

    Geritrex Recalls Senna Syrup Due to Atypical Odor and Taste

    Geritrex, LLC is recalling 1,536 bottles of Senna Syrup due to reports of atypical odor and unpleasant taste.

    Product
    Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1342-2019·2019-06-19

    Chiesi Recalls Zileuton Extended-Release Tablets Due to Dissolution Failure

    Chiesi USA is recalling 2,598 bottles of Zileuton Extended-Release Tablets, 600 mg, because they failed dissolution specifications.

    Product
    Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1406-2019·2019-06-19

    Synthetopes Recalls Sn-Pyrophosphate Kits Due to Processing Control Issues

    Synthetopes Inc. is recalling Sn-Pyrophosphate Kits because of a lack of processing controls. The recall covers all lots remaining within their expiry dates.

    Product
    Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1343-2019·2019-06-19

    B. Braun Recalls Heparin Sodium Bags Due to Low Potency

    B. Braun Medical Inc. is recalling 40,176 bags of Heparin Sodium in Dextrose because testing showed the drug had lower potency than required by USP specifications.

    Product
    HEPARIN SODIUM IN DEXTROSE — HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1395-2019·2019-06-19

    Pecgen DMX Recalled for Incorrect Pediatric Dosage Labeling

    Novis PR, Inc. is recalling Pecgen DMX cough syrup because a typo on the label provides incorrect dosage instructions for children.

    Product
    PECGEN DMX — PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1455-2019·2019-06-19

    Meiji Chocolate Choco Baby Recalled for Missing English Allergen Labels

    Wismettac Asian Foods is recalling Meiji Chocolate Choco Baby bars because they lack English labels for nutrition facts, ingredients, and allergens.

    Product
    CHOCOLATE CHOCO BABY (S) MEIJI, 1.19 oz. Item number 70582 UPC 074410705824 - only on those bars with English labeling. Distributed by Wismettac Asian Foods, Inc.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1437-2019·2019-06-19

    Geritrex Recalls Senna Syrup Due to Atypical Odor and Taste

    Geritrex, LLC is recalling Senna Syrup bottles due to reports of atypical odor and unpleasant taste.

    Product
    Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1751-2019·2019-06-19

    GE Healthcare Recalls Prestige Systems Due to Monitor Mount Failure

    GE Healthcare is recalling Prestige II, SI, and VH systems because a CRT monitor fell off its wall mount due to product aging.

    Product
    Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1456-2019·2019-06-19

    Laird Superfood Performance Mushrooms Recalled for Iron Labeling Error

    Laird Superfood is recalling Performance Mushrooms because the label incorrectly lists 14 mg of Iron instead of the actual 14 mcg.

    Product
    Performance Mushrooms product is dried mushroom blend of 4 different mushroom mycelial biomass powders cultured on certified organic oats, brand Laird Superfood, uses as Beverage Booster and Functional Fuel Supplement. Product is packaged in 3.17 oz (90 gram) stand up with zip
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1396-2019·2019-06-19

    Bausch & Lomb Recalls Lotemax Ophthalmic Gel for Viscosity Issues

    Bausch & Lomb is recalling Lotemax ophthalmic gel because it failed stability specifications for viscosity. The recall covers 17,083 bottles distributed nationwide.

    Product
    LOTEMAX — LOTEMAX (LOTEPREDNOL ETABONATE)
    Category
    Drug
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2019.