Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 23 of 87
Zydus Pharmaceuticals USA Inc
Class II Terminated
MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11
Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
D-1453-2019 June 26, 2019 Pennington, NJ
Zydus Pharmaceuticals USA Inc
Class II Terminated
MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34
Reason: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
D-1449-2019 June 26, 2019 Pennington, NJ
Torrent Pharma Inc
Class II Terminated
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.
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1362-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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, Di...
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1366-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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., ...
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1365-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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.
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1378-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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 Pharm...
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1381-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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.
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1347-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
Bisacodyl Suppositories, Brite Stock, Reese.
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1385-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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.
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1359-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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.
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1377-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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...
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1364-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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...
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1356-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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...
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1375-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1374-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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 ...
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1384-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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, Livoni...
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1354-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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 ...
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1369-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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.
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1371-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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...
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1373-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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, ...
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1370-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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.
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1368-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
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...
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1355-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076.
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1360-2019 June 19, 2019 Levittown, PA
Torrent Pharma Inc
Class II Terminated
Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin Pharma, Skokie, IL 60076.
Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
D-1358-2019 June 19, 2019 Levittown, PA