Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIHydrocortisone 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIMemantine 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIMemantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IILactulose 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IILactulose 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IINasal 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIDiphenhist 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIExtra 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IICough 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIKid 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: 0536-2310-97, Distributed by Rugby Laboratories, Livonia MI 48152.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIPain & 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIPhenobarbital 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIGuaifenesin 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., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Inc., Allendale, NJ 07401.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIGuaifenesin 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
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIAcetic 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IICetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIHyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIHyoscyamine 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IICyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin Pharma, Skokie, IL 60076.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIBiscolax 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIPedia 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, Distributed by Major Pharmaceuticals, Livonia MI 48152.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIRobafen 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IINasal 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIPseudoephedrine 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIBanophen 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 Pharmaceuticals, Livonia MI 48152.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIRobafen 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIRobafen 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIRobafen 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIChildren'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, Livonia MI 48152.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- 2019-06-19FDA-DrugTorrent Pharma IncClass IIAllergy 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.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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