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.

26–41 of 41

  • 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 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…
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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 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 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.
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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 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 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 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…
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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 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.
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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 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.
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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