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 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.
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    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
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  • 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., L
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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, L
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  • 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, Dist
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    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.
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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 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 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.
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    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.
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    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.
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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 13668-589-06, 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 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 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.
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    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.
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    0 states