Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1526-2019 | 05-31-2019 | Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16 | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC / 6213 bottles | Class II | Terminated |
| D-0610-2020 | 05-30-2019 | Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., CHATTANOOGA, TN., 37409, | Lack of sterility assurance. | Surgery Pharmacy Services Inc / 1149 bags | Class II | Terminated |
| D-0611-2020 | 05-30-2019 | Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.AVE. CHATT,TN37409 | Lack of sterility assurance. | Surgery Pharmacy Services Inc / 84 bags | Class II | Terminated |
| D-1402-2019 | 05-28-2019 | Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 20 vials | Class II | Terminated |
| D-1403-2019 | 05-28-2019 | Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 68 vials | Class II | Terminated |
| D-1404-2019 | 05-28-2019 | Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 82 vials | Class II | Terminated |
| D-1405-2019 | 05-28-2019 | Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / Unknown | Class II | Terminated |
| D-1406-2019 | 05-28-2019 | Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 45 vials | Class II | Terminated |
| D-1401-2019 | 05-28-2019 | Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 35 vials | Class II | Terminated |
| D-1400-2019 | 05-28-2019 | Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 3 vials | Class II | Terminated |
| D-1399-2019 | 05-28-2019 | Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc / 20 vials | Class II | Terminated |
| D-1395-2019 | 05-28-2019 | Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, Alcohol Free, Dye Free, Gluten Free, Cherry Raspberry Flavor, 16 Fl. oz. (474 mL), Manufactured in the USA for Kramer Novis, San Juan, PR 00917, www.kramernovis.com, NDC 52083-630-16. Package NDCs: 52083-630-16 | Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age. | Novis PR, Inc. / 5766 bottles | Class I | Terminated |
| D-1320-2019 | 05-23-2019 | Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20 Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Complaint received of metal piece identified in the product bottle prior to the reconstitution. | Lupin Pharmaceuticals Inc. / 18,408, 60 mL bottles | Class II | Terminated |
| D-1322-2019 | 05-23-2019 | Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 716 vials | Class II | Terminated |
| D-1324-2019 | 05-23-2019 | Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 26 vails | Class II | Terminated |
| D-1328-2019 | 05-23-2019 | Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 669 vials | Class II | Terminated |
| D-1337-2019 | 05-23-2019 | Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 371 vials | Class II | Terminated |
| D-1323-2019 | 05-23-2019 | B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1611-30 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 4 vials | Class II | Terminated |
| D-1333-2019 | 05-23-2019 | Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 100 vials | Class II | Terminated |
| D-1330-2019 | 05-23-2019 | Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 24 vials | Class II | Terminated |
| D-1335-2019 | 05-23-2019 | Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 25 vials | Class II | Terminated |
| D-1338-2019 | 05-23-2019 | Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-10 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / a) 114 vials and b) 566 vials | Class II | Terminated |
| D-1325-2019 | 05-23-2019 | Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 279 vials | Class II | Terminated |
| D-1329-2019 | 05-23-2019 | Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 50 vials | Class II | Terminated |
| D-1326-2019 | 05-23-2019 | Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 104 vials | Class II | Terminated |
| D-1331-2019 | 05-23-2019 | Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 6 vials | Class II | Terminated |
| D-1334-2019 | 05-23-2019 | Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 1 vial | Class II | Terminated |
| D-1332-2019 | 05-23-2019 | Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 66 vials | Class II | Terminated |
| D-1327-2019 | 05-23-2019 | Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 11 vials | Class II | Terminated |
| D-1336-2019 | 05-23-2019 | Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-30 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 704 vials | Class II | Terminated |
| D-1339-2019 | 05-23-2019 | Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Lack of Sterility Assurance. | Pharm D Solutions, LLC / 4 vials | Class II | Terminated |
| D-1386-2019 | 05-22-2019 | Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20 Package NDCs: 63323-373-00; 63323-373-02; 63323-374-20 | Failed Impurities/Degradation Specifications. | Fresenius Kabi USA, LLC / 11,981 units | Class III | Terminated |
| D-1360-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 24,384 bottles | Class II | Terminated |
| D-1345-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 48,955 bottles | Class II | Terminated |
| D-1385-2019 | 05-21-2019 | Bisacodyl Suppositories, Brite Stock, Reese. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / N/A | Class II | Terminated |
| D-1369-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 176,580 bottles | Class II | Terminated |
| D-1368-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 249,744 bottles | Class II | Terminated |
| D-1367-2019 | 05-21-2019 | 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: 0536-2310-97, Distributed by Rugby Laboratories, Livonia MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 66,060 bottles | Class II | Terminated |
| D-1362-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 14,016 bottles | Class II | Terminated |
| D-1373-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 153.540 bottles | Class II | Terminated |
| D-1364-2019 | 05-21-2019 | 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., 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). | Torrent Pharma Inc / 6,000 bottles | Class II | Terminated |
| D-1348-2019 | 05-21-2019 | 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, Livonia MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 2,646,228 bottles | Class II | Terminated |
| D-1381-2019 | 05-21-2019 | 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.. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 730,476 bottles | Class II | Terminated |
| D-1371-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 62,748 bottles | Class II | Terminated |
| D-1353-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 1,436,904 bottles | Class II | Terminated |
| D-1351-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 1,500,672 bottles | Class II | Terminated |
| D-1347-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 118,080 bottles | Class II | Terminated |
| D-1349-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 984,888 bottles | Class II | Terminated |
| D-1358-2019 | 05-21-2019 | Cyproheptadine 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). | Torrent Pharma Inc / 66,798 bottles | Class II | Terminated |
| D-1365-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 148,440 bottles | Class II | Terminated |
| D-1357-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 391,404 cartons | Class II | Terminated |
| D-1379-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 177,408 bottles | Class II | Terminated |
| D-1377-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 120,204 cartons | Class II | Terminated |
| D-1356-2019 | 05-21-2019 | 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, Distributed by Major Pharmaceuticals, Livonia MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 17,748 bottles | Class II | Terminated |
| D-1372-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 96,060 bottles | Class II | Terminated |
| D-1359-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 53,520 bottles | Class II | Terminated |
| D-1370-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 438,624 bottles | Class II | Terminated |
| D-1361-2019 | 05-21-2019 | Cetirizine 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). | Torrent Pharma Inc / 361,260 bottles | Class II | Terminated |
| D-1378-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 82,872 bottles | Class II | Terminated |
| D-1352-2019 | 05-21-2019 | 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 Pharmaceuticals, Livonia MI 48152. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 655,104 bottles | Class II | Terminated |
| D-1354-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 3,788,502 bottles | Class II | Terminated |
| D-1350-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 131,328 bottles | Class II | Terminated |
| D-1376-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 140,436 suppositories | Class II | Terminated |
| D-1363-2019 | 05-21-2019 | 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 | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 233,388 bottles | Class II | Terminated |
| D-1355-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 262,008 bottles | Class II | Terminated |
| D-1366-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 1,883,796 bottles | Class II | Terminated |
| D-1374-2019 | 05-21-2019 | Memantine 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). | Torrent Pharma Inc / 5,681 bottles | Class II | Terminated |
| D-1346-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 58,272 bottles | Class II | Terminated |
| D-1384-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 7,728 bottles | Class II | Terminated |
| D-1380-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 1,126,404 bottles | Class II | Terminated |
| D-1383-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 11,112 bottles | Class II | Terminated |
| D-1382-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 52,368 bottles | Class II | Terminated |
| D-1375-2019 | 05-21-2019 | 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. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc / 264 bottles | Class II | Terminated |
| D-1398-2019 | 05-21-2019 | AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32 Package NDCs: 23155-290-31; 23155-290-41; 23155-290-32; 23155-290-42 | Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) . | Heritage Pharmaceuticals, Inc. / 14,960 4 mL vials | Class I | Terminated |
| D-1397-2019 | 05-21-2019 | PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31 Package NDCs: 23155-294-31; 23155-294-42; 23155-294-41 | Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) . | Heritage Pharmaceuticals, Inc. / 55,480 2 mL vials | Class I | Terminated |
| D-1391-2019 | 05-20-2019 | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310 | Failed Impurities/Degradation Specifications | Teligent Pharma, Inc. / 9360 tubes | Class III | Terminated |
| D-1294-2019 | 05-13-2019 | Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60 Package NDCs: 64764-080-60; 64764-080-40; 64764-240-60; 64764-240-10; 64764-240-40 | Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue. | MALLINCKRODT PHARMACEUTICALS / 89,808 bottles | Class II | Terminated |
| D-1434-2019 | 05-13-2019 | Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25 | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | American Health Packaging / 6,643 cartons | Class II | Terminated |
| D-1431-2019 | 05-13-2019 | Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25 | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | American Health Packaging / 3,015 cartons | Class II | Terminated |
| D-1432-2019 | 05-13-2019 | Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01 | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | American Health Packaging / 16,698 cartons | Class II | Terminated |
| D-1433-2019 | 05-13-2019 | Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25 | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | American Health Packaging / 8,777 cartons | Class II | Terminated |
| D-1295-2019 | 05-13-2019 | Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60 Package NDCs: 64764-080-60; 64764-080-40; 64764-240-60; 64764-240-10; 64764-240-40 | Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue. | MALLINCKRODT PHARMACEUTICALS / 80,640 bottles | Class II | Terminated |
| D-1309-2019 | 05-11-2019 | Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ireland, NDC 0078-0972-61. Package NDCs: 0078-0684-15; 0078-0685-15; 0078-0686-15; 0078-0686-55; 0078-0687-15; 0078-0972-19; 0078-0972-23; 0078-0972-61; 0078-0697-19; 0078-0697-23; 0078-0697-61 | Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour. | Novartis Pharmaceuticals Corp. / 792 cartons | Class I | Terminated |
| D-1393-2019 | 05-10-2019 | QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz cans, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102-1390 USA, NDC 47593-490-82 Package NDCs: 47593-490-82; 47593-490-87 | Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material. | Ecolab Inc / 183 cases | Class III | Terminated |
| D-1467-2019 | 05-09-2019 | Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories Package NDCs: 68001-155-04; 68001-155-08 | GMP Deviations: Potential cross contamination due to cleaning procedure failure. | American Health Packaging / 375,921 bottles | Class II | Terminated |
| D-1394-2019 | 05-09-2019 | Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC 60687-112-21. Package NDCs: 60687-112-11; 60687-112-21 | GMP Deviations: Potential cross contamination due to cleaning procedure failure. | American Health Packaging / 15,386 cartons | Class II | Terminated |
| D-1449-2019 | 05-06-2019 | 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 Package NDCs: 68382-916-01; 68382-916-05; 68382-916-34; 68382-917-11; 68382-917-01; 68382-917-05; 68382-917-30; 68382-917-77; 68382-918-18; 68382-918-01; 68382-918-05; 68382-918-30; 68382-918-77; 68382-919-11; 68382-919-01; 68382-919-05; 68382-919-30; 68382-919-77 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / N/A | Class II | Terminated |
| D-1450-2019 | 05-06-2019 | MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18 Package NDCs: 68382-916-01; 68382-916-05; 68382-916-34; 68382-917-11; 68382-917-01; 68382-917-05; 68382-917-30; 68382-917-77; 68382-918-18; 68382-918-01; 68382-918-05; 68382-918-30; 68382-918-77; 68382-919-11; 68382-919-01; 68382-919-05; 68382-919-30; 68382-919-77 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / N/A | Class II | Terminated |
| D-1448-2019 | 05-06-2019 | MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01 Package NDCs: 68382-916-01; 68382-916-05; 68382-916-34; 68382-917-11; 68382-917-01; 68382-917-05; 68382-917-30; 68382-917-77; 68382-918-18; 68382-918-01; 68382-918-05; 68382-918-30; 68382-918-77; 68382-919-11; 68382-919-01; 68382-919-05; 68382-919-30; 68382-919-77 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / 34521 100-count bottles | Class II | Terminated |
| D-1447-2019 | 05-06-2019 | Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / 113,304 90-count bottles | Class II | Terminated |
| D-1442-2019 | 05-06-2019 | Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / 204 1000-count bottles | Class II | Terminated |
| D-1321-2019 | 05-06-2019 | The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet. | Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis. | Stiff Boy LLC / 1000 boxes | Class I | Terminated |
| D-1443-2019 | 05-06-2019 | Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / 143,184 90-count bottles | Class II | Terminated |
| D-1444-2019 | 05-06-2019 | Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / 215,760 90-count bottles | Class II | Terminated |
| D-1451-2019 | 05-06-2019 | MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11 Package NDCs: 68382-916-01; 68382-916-05; 68382-916-34; 68382-917-11; 68382-917-01; 68382-917-05; 68382-917-30; 68382-917-77; 68382-918-18; 68382-918-01; 68382-918-05; 68382-918-30; 68382-918-77; 68382-919-11; 68382-919-01; 68382-919-05; 68382-919-30; 68382-919-77 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / 13,564 25-count bottles | Class II | Terminated |
| D-1453-2019 | 05-06-2019 | MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11 Package NDCs: 68382-916-01; 68382-916-05; 68382-916-34; 68382-917-11; 68382-917-01; 68382-917-05; 68382-917-30; 68382-917-77; 68382-918-18; 68382-918-01; 68382-918-05; 68382-918-30; 68382-918-77; 68382-919-11; 68382-919-01; 68382-919-05; 68382-919-30; 68382-919-77 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / 40872 25-count bottles | Class II | Terminated |
| D-1452-2019 | 05-06-2019 | Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / 47,664 90-count bottles | Class II | Terminated |
| D-1445-2019 | 05-06-2019 | Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / 3,156 1000-count bottles | Class II | Terminated |
| D-1441-2019 | 05-06-2019 | Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10 Package NDCs: 68382-209-06; 68382-209-10 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / 768 1000-count bottles | Class II | Terminated |
| D-1440-2019 | 05-06-2019 | ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06 Package NDCs: 68382-209-06; 68382-209-10 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / 1,425,264 30-count bottles | Class II | Terminated |
