The Recall Desk

FDA (Drugs) recall action 82889

Torrent Pharma Inc recalled 41 products on 2019-06-19

The FDA (Drugs) publishes a recall like this one as 41 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 41 pages.

Products
41
Announced
2019-06-19
Critical
0
Units
18,376,464

Why these products were recalled

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 41

  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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.…
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-06-19

    Torrent Pharma Recalls Phenobarbital Oral Solution Due to Potential Bacterial Contamination

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

    Product
    Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle, NDC:16571-330-16, Manufactured by Bio-Pharm Inc., Levittown, PA 10957, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-06-19

    Kid Kare Children's Cough/Cold Liquid Recalled for Bacterial Contamination

    Torrent Pharma is recalling Kid Kare Children's Cough/Cold Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg, Dextromethorphan HBr, USP 10 mg, Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10mL)), 4 Fl. oz. bottle, NDC…
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-06-19

    Torrent Pharma Recalls Memantine Hydrochloride Oral Solution Due to Contamination Risk

    Torrent Pharma Inc. is recalling 264 bottles of Memantine Hydrochloride Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured By Bio-Pharm Inc., Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-06-19

    Torrent Pharma Recalls Guaifenesin AC Cough Syrup Due to Bacterial Contamination

    Torrent Pharma Inc. is recalling specific lots of Guaifenesin AC Cough Syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-06-19

    Torrent Pharma Recalls Robafen DM Syrup Due to Bacterial Contamination Risk

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

    Product
    Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0053-00, b) 8 oz. bottle, NDC: 0904-0053-09, c) 16 oz. bottle, NDC:0904-0053-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states