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 08, 2025 and include a total of 16999 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 / N/A | Class I | Completed |
| 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 |
| 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-1446-2019 | 05-06-2019 | Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16 | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc / 168,330 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-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-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-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-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-1436-2019 | 05-06-2019 | Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08 | Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported | Geritrex, LLC / 1536 units | Class II | Terminated |
| D-1437-2019 | 05-06-2019 | Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08 | Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported | Geritrex, LLC / 24312 units | 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-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-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-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-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-1289-2019 | 05-03-2019 | Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-09 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Heritage Pharmaceuticals, Inc. / 34403 bottles | Class II | Terminated |
| D-1290-2019 | 05-03-2019 | Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-10 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Heritage Pharmaceuticals, Inc. / 3697 bottles | Class II | Terminated |
| D-1291-2019 | 05-03-2019 | Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-644-09 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Heritage Pharmaceuticals, Inc. / 15541 bottles | Class II | Terminated |
| D-1288-2019 | 05-03-2019 | Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-09 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Heritage Pharmaceuticals, Inc. / 25220 bottles | Class II | Terminated |
| D-1308-2019 | 05-03-2019 | Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOENIX, AZ 85085, NDC 42852-001-27 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 730 syringes | Class II | Terminated |
| D-1287-2019 | 05-03-2019 | Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-10 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Heritage Pharmaceuticals, Inc. / 3012 bottles | Class II | Terminated |
| D-1307-2019 | 05-02-2019 | Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-601-16 Reorder #: 51116 Package NDCs: 66312-601-16; 66312-602-16 | Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL. | Septodont Inc. / 240 cartons of 50 glass cartridges each | Class II | Terminated |
| D-1299-2019 | 05-02-2019 | DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL), Cherry Flavor, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-011-20, UPC 370302223019 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 280 cartons | Class II | Terminated |
| D-1303-2019 | 05-02-2019 | DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302489019 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 39216 cartons | Class II | Terminated |
| D-1298-2019 | 05-02-2019 | DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, 0.17 fl. oz. (5 mL), Mixed Berry, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-012-20, UPC 370302255010 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 1060 cartons | Class II | Terminated |
| D-1301-2019 | 05-02-2019 | DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 1344 cartons | Class II | Terminated |
| D-1306-2019 | 05-02-2019 | CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01, UPC 050428598368 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 21456 cartons | Class II | Terminated |
| D-1300-2019 | 05-02-2019 | CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution Antihistamine Mixed Berry Flavor 20 Single-Use 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-261-01, UPC 050428597156 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 27840 cartons | Class II | Terminated |
| D-1302-2019 | 05-02-2019 | CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 050428597958 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 38640 cartons | Class II | Terminated |
| D-1296-2019 | 05-02-2019 | CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor 20 Single-Use Vials per carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-0258-01, UPC 050428601891 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 15264 cartons | Class II | Terminated |
| D-1304-2019 | 05-02-2019 | CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 23712 cartons | Class II | Terminated |
| D-1305-2019 | 05-02-2019 | DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials, Drug Free, Manufactured by: Unipharma, LLC. Tamarac, FL 33321, a) 0.02 fl. oz. (0.5 mL), UPC 370302446081; b) 0.05 fl. oz. (1.5 mL), UPC 370302446098 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 816 cartons | Class II | Terminated |
| D-1297-2019 | 05-02-2019 | CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-260-01, UPC 050428597675 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 33360 cartons | Class II | Terminated |
| D-1283-2019 | 05-01-2019 | Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Golden State Medical Supply Inc. / 64,362 HDPE bottles | Class II | Terminated |
| D-1284-2019 | 05-01-2019 | Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Golden State Medical Supply Inc. / 11,286 HDPE Bottles | Class II | Terminated |
| D-1286-2019 | 05-01-2019 | Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Golden State Medical Supply Inc. / 8,767 HDPE Bottles | Class II | Terminated |
| D-1285-2019 | 05-01-2019 | Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Golden State Medical Supply Inc. / 138,213 HDPE Bottles | Class II | Terminated |
| D-1282-2019 | 05-01-2019 | Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Golden State Medical Supply Inc. / 11,668 HDPE bottles | Class II | Terminated |
| D-1274-2019 | 04-30-2019 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02 Package NDCs: 25021-700-01; 25021-701-01; 25021-701-02 | Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products. | Sagent Pharmaceuticals Inc / 75,825 vials | Class II | Terminated |
| D-0018-2021 | 04-30-2019 | Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer | Direct Rx / 33 bottles | Class II | Terminated |
| D-1293-2019 | 04-30-2019 | Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044 Package NDCs: 42023-172-04 | Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product | Par Pharmaceutical, Inc. / 4506 packs | Class I | Terminated |
| D-1281-2019 | 04-30-2019 | Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | Preferred Pharmaceuticals, Inc / | Class II | Terminated |
| D-1278-2019 | 04-29-2019 | Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017. Package NDCs: 0049-2330-79; 0049-2330-45; 0049-2340-79; 0049-2340-45; 0049-2340-05 | Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton. | Pfizer Inc. / 100277 tablets | Class III | Terminated |
| D-1251-2019 | 04-26-2019 | HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10 | Sub-potency | Advanced Pharma Inc. / 560 bags | Class II | Terminated |
| D-1273-2019 | 04-25-2019 | Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05 Package NDCs: 68382-092-17; 68382-092-01; 68382-092-05; 68382-093-17; 68382-093-05; 68382-093-01; 68382-094-17; 68382-094-01; 68382-094-05; 68382-095-17; 68382-095-01; 68382-095-05 | Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg | Zydus Pharmaceuticals USA Inc / 3900 | Class II | Terminated |
| D-1275-2019 | 04-25-2019 | Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67 | Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis. | US Worldmeds LLC / 6456 vials | Class II | Terminated |
| D-1279-2019 | 04-25-2019 | Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6 | Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz. | Advantice Health / 111,492 canisters total | Class III | Terminated |
| D-1272-2019 | 04-25-2019 | Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-791-01 Package NDCs: 68382-791-06; 68382-791-16; 68382-791-01; 68382-791-05; 68382-791-10; 68382-791-30; 68382-792-06; 68382-792-16; 68382-792-01; 68382-792-05; 68382-792-10; 68382-792-30 | Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg | Zydus Pharmaceuticals USA Inc / N/A | Class II | Terminated |
| D-1280-2019 | 04-25-2019 | Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; Product Code 80-6802; Case UPC 1 03 16864 68002 7. | Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz. | Advantice Health / 111,492 canisters total | Class III | Terminated |
| D-1249-2019 | 04-24-2019 | Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million. | AVKARE Inc. / 1438 cartons (71,900 tablets) | Class II | Ongoing |
| D-1250-2019 | 04-24-2019 | Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million. | AVKARE Inc. / 846 cartons (42,300 tablets) | Class II | Ongoing |
| D-1263-2019 | 04-24-2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54 | CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API) | Legacy Pharmaceutical Packaging LLC / 60,012 bottles | Class II | Ongoing |
| D-1583-2019 | 04-24-2019 | DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61. Package NDCs: 0904-6363-45; 0904-6363-61 | cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. | MAJOR PHARMACEUTICALS / 828 100-count unit dose cartons | Class II | Terminated |
| D-1241-2019 | 04-23-2019 | Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25 | Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing. | Akorn Inc / 5,380 cartons (25 ampules per carton) | Class III | Terminated |
| D-1292-2019 | 04-23-2019 | Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020 | Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil. | D.B.P. Distribution / unknown | Class I | Terminated |
| D-1316-2019 | 04-22-2019 | Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml Universal Valve pouches per case, 5013-404, d) 1 gallon bottles, 4/1 gallon bottles per case, 5013-420-02, INOPAK, LTD., 24 Executive Parkway, Ringwood, NJ 07456. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1313-2019 | 04-22-2019 | INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1315-2019 | 04-22-2019 | Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY 10566 | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1270-2019 | 04-22-2019 | Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00. | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million. | RemedyRepack Inc. / 44 HDPE bottles of 90 = 3,960 tablets | Class II | Terminated |
| D-1242-2019 | 04-22-2019 | Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05 Package NDCs: 68382-092-17; 68382-092-01; 68382-092-05; 68382-093-17; 68382-093-05; 68382-093-01; 68382-094-17; 68382-094-01; 68382-094-05; 68382-095-17; 68382-095-01; 68382-095-05 | Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg. | Zydus Pharmaceuticals USA Inc / 7668 bottles | Class III | Terminated |
| D-1312-2019 | 04-22-2019 | Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera & Vitamin E, packaged in a) 1000 ml Disc Pump pouches (NDC 58575-340), 8 x 1000 ml Disc Pump pouches per case, Product Code 5025-L1000; b) 2 fl. oz. bottles, 80/2 oz bottles per case, 5025-480-02; c) 18 fl. oz. bottles (NDC 58575-340), 16/18 oz bottles per case, 5025-430-02; d) 8 FL OZ. bottle, 24/8 oz bottle per case, 5025-440-03; e) 4 fl. oz. bottles, 24 x 4oz. Bottles per case, 5025-450-03; f) 800 ml pouches, 12 x 800 ml Universal Valve pouches per case, 5025-404-NB; g) 1 Gallon bottles, 4/1 gallon bottles per case, 5025-4202-02; Inopak LTD., Ringwood, NJ 07456. SaniTyze Hand Sanitizer with Aloe Vera, Vitamin E & Keratin, packaged as h) 8 fl oz (237 ml) bottles, 24/ 8 Oz. bottles per case; Manufactured for Crosstex International, Inc., 10 Rarick Road, Hauppague, NY 11788-4209. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1317-2019 | 04-22-2019 | Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1310-2019 | 04-22-2019 | ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6/1000ML pouches per case, 5063-OS1000; d) INOFOAM Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6-1000ml pouches per case, 5063-FL1000, Inopak LTD., 24 Executive Parkway, Ringwood, NJ 07456. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1311-2019 | 04-22-2019 | AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris Pharmaceuticals (Division of Inopak). | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1314-2019 | 04-22-2019 | INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1318-2019 | 04-22-2019 | Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches, 12/800 ML Universal Valve pouches per case, 5031-404, d) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, e) 800 ml pouches, 12 x 800ML. KC Valve pouches per case, 5031-404-KC, f) 800 ml pouches, 12/800 ML Universal Valve pouches per case, 5031-404, g) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, h) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, i) 500 ml pouches, 18/500 ML. KC Valve pouches per case, 5031-404-500, j) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, k) 8 oz. bottles, 24/8 OZ. bottles with pumps per case, 5031-440-03, l) 18 oz. bottles, 16 x 18 OZ. Bottles with Pumps per case, 5031-430-02, m) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, n) 1000 ml pouches, 8/1000ML. Disc Pumps pouches per case, 5031-L1000; Choice Antibacterial Hand Soap, packaged as o) 800 ml/27fl.oz. pouches, 12/800 ml Universal Valve pouches per case, 5031-404UV-CH, Manufactured by Inopak LTD., Ringwood, NJ. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1319-2019 | 04-22-2019 | Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401 North 10th Street, Philadelphia, PA 19123. | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd / 17,850 pounds per batch | Class II | Terminated |
| D-1277-2019 | 04-19-2019 | FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47. Package NDCs: 47781-423-11; 47781-423-47; 47781-424-11; 47781-424-47; 47781-426-11; 47781-426-47; 47781-427-11; 47781-427-47; 47781-428-11; 47781-428-47 | Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h. | Alvogen, Inc / 119,608 cartons | Class I | Terminated |
| D-1271-2019 | 04-19-2019 | BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biologic product was repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901 Lot:190212AB BUD:5/13/2019, Repackaged on 2/12/2019 | Defective Delivery System: difficult to express | Pacifico National, Inc. dba AmEx Pharmacy / 249 syringes | Class II | Terminated |
| D-1265-2019 | 04-18-2019 | Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 164,424 bottles | Class II | Ongoing |
| D-1266-2019 | 04-18-2019 | Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 65,184 bottles | Class II | Ongoing |
| D-1264-2019 | 04-18-2019 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 28,464 bottles | Class II | Ongoing |
| D-1269-2019 | 04-18-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 239,016 bottles | Class II | Ongoing |
