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 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.
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    0 states
  • SevereFDA (Drugs)··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.
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    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
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    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.
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    0 states
  • SevereFDA (Drugs)··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.
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    0 states
  • SevereFDA (Drugs)··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.
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    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.
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    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.
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    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..
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  • SevereFDA (Drugs)··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.
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    0 states
  • 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.
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    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.
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    0 states
  • SevereFDA (Drugs)··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.
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    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.
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    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 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816.
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    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
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    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: 0536-2310
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  • 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.
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    0 states
  • SevereFDA (Drugs)··2019-06-19

    Torrent Pharma Recalls Robafen AC Oral Solution Due to Bacterial Contamination

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

    Product
    Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6479-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
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    0 states
  • SevereFDA (Drugs)··2019-06-19

    Torrent Pharma Recalls Acetaminophen Oral Solution Due to Bacterial Contamination

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

    Product
    Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored, a) 4 Fl. oz. bottle, NDC: 0536-0122-97, b) One Pint (473 mL) bottle, NDC: 0536-0122-85, Distributed by Rugby Laboratories, Lavonia, MI 48152 USA.
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    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.
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    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.
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    0 states
  • SevereFDA (Drugs)··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.
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    0 states