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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1236-2020 | 03-18-2020 | Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01 Package NDCs: 13107-105-30; 13107-105-01; 13107-106-30; 13107-106-01 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 2101 units | Class II | Terminated |
| D-1232-2020 | 03-18-2020 | Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99 Package NDCs: 65862-198-01; 65862-198-05; 65862-198-99; 65862-198-10; 65862-198-90; 65862-198-18; 65862-198-27; 65862-199-01; 65862-199-05; 65862-199-99; 65862-199-10; 65862-199-30; 65862-199-60; 65862-199-90; 65862-199-18; 65862-199-27; 65862-200-01; 65862-200-05; 65862-200-10; 65862-200-90; 65862-200-27 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 26625 units | Class II | Terminated |
| D-1235-2020 | 03-18-2020 | Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34 Package NDCs: 13107-001-30; 13107-001-60; 13107-001-90; 13107-001-01; 13107-001-05; 13107-031-30; 13107-031-34; 13107-031-60; 13107-031-90; 13107-031-01; 13107-031-05; 13107-031-32; 13107-003-30; 13107-003-34; 13107-003-60; 13107-003-90; 13107-003-01; 13107-003-05; 13107-003-32; 13107-032-34; 13107-032-60; 13107-032-90; 13107-032-01; 13107-032-05; 13107-032-32 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 56208 units | Class II | Terminated |
| D-1234-2020 | 03-18-2020 | Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90 Package NDCs: 65862-050-30; 65862-050-45; 65862-050-90; 65862-050-01; 65862-050-00; 65862-050-99; 65862-050-26; 65862-051-30; 65862-051-45; 65862-051-90; 65862-051-01; 65862-051-00; 65862-051-99; 65862-051-26; 65862-052-30; 65862-052-45; 65862-052-90; 65862-052-01; 65862-052-00; 65862-052-99; 65862-052-26; 65862-053-30; 65862-053-45; 65862-053-90; 65862-053-01; 65862-053-00; 65862-053-99; 65862-053-22; 65862-054-30; 65862-054-45; 65862-054-90; 65862-054-00; 65862-054-99; 65862-054-39 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 26976 units | Class II | Terminated |
| D-1231-2020 | 03-18-2020 | Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01 Package NDCs: 13107-058-30; 13107-058-01; 13107-058-05; 13107-058-99; 13107-059-30; 13107-059-01; 13107-059-05; 13107-059-99; 13107-060-30; 13107-060-01; 13107-060-05; 13107-060-99 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 57337 units | Class II | Terminated |
| D-1229-2020 | 03-18-2020 | Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01 Package NDCs: 13107-058-30; 13107-058-01; 13107-058-05; 13107-058-99; 13107-059-30; 13107-059-01; 13107-059-05; 13107-059-99; 13107-060-30; 13107-060-01; 13107-060-05; 13107-060-99 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 14194 units | Class II | Terminated |
| D-1237-2020 | 03-18-2020 | Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01 Package NDCs: 13107-043-30; 13107-043-01; 13107-043-05; 13107-043-99; 13107-044-30; 13107-044-01; 13107-044-05; 13107-044-99; 13107-045-30; 13107-045-01; 13107-045-05; 13107-045-99; 13107-046-30; 13107-046-01; 13107-046-05; 13107-046-99 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 14707 units | Class II | Terminated |
| D-1230-2020 | 03-18-2020 | Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99 Package NDCs: 13107-058-30; 13107-058-01; 13107-058-05; 13107-058-99; 13107-059-30; 13107-059-01; 13107-059-05; 13107-059-99; 13107-060-30; 13107-060-01; 13107-060-05; 13107-060-99 | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed | Aurobindo Pharma USA Inc. / 4332 units | Class II | Terminated |
| D-1066-2020 | 03-16-2020 | Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95 Package NDCs: 0573-0169-17; 0573-0169-02; 0573-0169-19; 0573-0169-20; 0573-0169-40; 0573-0169-11; 0573-0169-89; 0573-0169-30; 0573-0169-31; 0573-0169-86; 0573-0169-51; 0573-0169-43; 0573-0169-49; 0573-0169-52; 0573-0169-08; 0573-0169-22; 0573-0169-13; 0573-0169-76; 0573-0169-16; 0573-0149-13; 0573-0149-04; 0573-0149-66; 0573-0149-91; 0573-1769-20; 0573-1769-80; 0573-1769-89; 0573-1769-14; 0573-1769-13; 0573-1769-09; 0573-1769-02; 0573-1769-87; 0573-1769-16; 0573-1769-31; 0573-1769-92; 0573-1769-95; 0057317698 | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. | Glaxosmithkline Consumer Healthcare Holdings / 446,628 bottles | Class II | Terminated |
| D-1065-2020 | 03-16-2020 | Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister Package NDCs: 0573-0196-01; 0573-0196-10; 0573-0196-20; 0573-0196-02; 0573-2161-03; 0057301961; 0057301962 | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. | Glaxosmithkline Consumer Healthcare Holdings / 471,024 blisters | Class II | Terminated |
| D-1086-2020 | 03-16-2020 | succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 2475 units | Class II | Terminated |
| D-1089-2020 | 03-16-2020 | fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 290 units | Class II | Terminated |
| D-1091-2020 | 03-16-2020 | ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 900 units | Class II | Terminated |
| D-1088-2020 | 03-16-2020 | ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 375 units | Class II | Terminated |
| D-1084-2020 | 03-16-2020 | HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 1840 units | Class II | Terminated |
| D-1085-2020 | 03-16-2020 | fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 210 units | Class II | Terminated |
| D-1092-2020 | 03-16-2020 | fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 75 units | Class II | Terminated |
| D-1087-2020 | 03-16-2020 | rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 2250 units | Class II | Terminated |
| D-1090-2020 | 03-16-2020 | ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 1500 units | Class II | Terminated |
| D-1093-2020 | 03-16-2020 | fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 1350 units | Class II | Terminated |
| D-1081-2020 | 03-16-2020 | ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 1075 units | Class II | Terminated |
| D-1082-2020 | 03-16-2020 | nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 80 units | Class II | Terminated |
| D-1067-2020 | 03-16-2020 | Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.) Package NDCs: 0573-0191-20; 0573-0191-50; 0573-0191-22; 0573-0191-75; 0057301917; 0057301915 | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. | Glaxosmithkline Consumer Healthcare Holdings / 151,056 bottles | Class II | Terminated |
| D-1094-2020 | 03-16-2020 | Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. Package NDCs: 43598-405-11; 43598-405-16 | Defective Container: Recall is due to breaking and shattering of ampules upon opening | Dr. Reddy's Laboratories, Inc. / 10943 cartons | Class I | Terminated |
| D-1069-2020 | 03-16-2020 | Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. | Glaxosmithkline Consumer Healthcare Holdings / 4,104 bottles | Class II | Terminated |
| D-1080-2020 | 03-16-2020 | Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501 | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction | Y-O Management LLC, dba Natural Remedy Store / 19156 packets estimated distributed | Class I | Terminated |
| D-1068-2020 | 03-16-2020 | Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. | Glaxosmithkline Consumer Healthcare Holdings / 566 blister packs | Class II | Terminated |
| D-1072-2020 | 03-16-2020 | Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail Port Charlotte, FL 33952 | Lack of Assurance of Sterility | The Medicine Shoppe Pharmacy / 4 bottles | Class II | Terminated |
| D-1083-2020 | 03-16-2020 | rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10 | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | PharMEDium Services, LLC / 4625 units | Class II | Terminated |
| D-1076-2020 | 03-13-2020 | C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Medical Center Pharmacy, Inc. / 2 bags | Class II | Terminated |
| D-1074-2020 | 03-13-2020 | C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Medical Center Pharmacy, Inc. / 1 bottle | Class II | Terminated |
| D-1077-2020 | 03-13-2020 | *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Medical Center Pharmacy, Inc. / 2 bottles | Class II | Terminated |
| D-1075-2020 | 03-13-2020 | *Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 00409-1134-03. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Medical Center Pharmacy, Inc. / 1 cassette | Class II | Terminated |
| D-1073-2020 | 03-13-2020 | C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Medical Center Pharmacy, Inc. / 2 bottles | Class II | Terminated |
| D-1032-2020 | 03-13-2020 | Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01. Package NDCs: 63304-614-20; 63304-614-05; 63304-614-01; 63304-614-13; 63304-615-05; 63304-615-11; 63304-615-01; 63304-616-20; 63304-616-05; 63304-616-01; 63304-616-13; 63304-616-50 | CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions. | Sun Pharmaceutical Industries, Inc. / 624 bottles | Class II | Terminated |
| D-1033-2020 | 03-13-2020 | Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50. Package NDCs: 63304-614-20; 63304-614-05; 63304-614-01; 63304-614-13; 63304-615-05; 63304-615-11; 63304-615-01; 63304-616-20; 63304-616-05; 63304-616-01; 63304-616-13; 63304-616-50 | CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions. | Sun Pharmaceutical Industries, Inc. / 172,320 bottles | Class II | Terminated |
| D-1058-2020 | 03-11-2020 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90 | CGMP Deviations: Presence of dark brown discoloration on edges of tablets | Jubilant Cadista Pharmaceuticals, Inc. / 89,376 90-count bottles | Class II | Terminated |
| D-1053-2020 | 03-10-2020 | Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy / 403 troches | Class II | Terminated |
| D-1054-2020 | 03-10-2020 | Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy / 89 troches | Class II | Terminated |
| D-1052-2020 | 03-10-2020 | Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida | Subpotent Drug | Matthew 7:25 Inc dba Thrive Pharmacy / 71 troches | Class II | Terminated |
| D-1047-2020 | 03-09-2020 | Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05 Package NDCs: 63304-828-90; 63304-828-05; 63304-827-90; 63304-827-05; 63304-829-90; 63304-829-05; 63304-830-90; 63304-830-05 | Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg. | Sun Pharmaceutical Industries, Inc. / 1416 bottles | Class II | Terminated |
| D-1055-2020 | 03-09-2020 | Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA. | Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity. | Lupin Pharmaceuticals Inc. / 1,712 cartons | Class III | Terminated |
| D-1031-2020 | 03-09-2020 | Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01 | Presence of particulate matter. presence of metal particles. | Mylan Pharmaceuticals Inc. / 300 100-count bottles | Class II | Terminated |
| D-1056-2020 | 03-09-2020 | Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA. | Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity. | Lupin Pharmaceuticals Inc. / 9,897 cartons | Class II | Terminated |
| D-1005-2020 | 03-06-2020 | Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433 | Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle | H J Harkins Company Inc dba Pharma Pac / 11,973 tablets | Class II | Terminated |
| D-1059-2020 | 03-06-2020 | Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01. | CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date. | Nostrum Laboratories Inc / 4722 bottles | Class II | Terminated |
| D-1260-2020 | 03-05-2020 | Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27 Package NDCs: 0093-5986-19; 0093-5986-27; 0093-5985-19; 0093-5985-27 | CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component. | Teva Pharmaceuticals USA / 600 cartons/2 auto-injector per carton | Class II | Terminated |
| D-1064-2020 | 03-05-2020 | Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451 | CGMP Deviation: Chemical indicators were not positioned properly during sterilization process. | Fresenius Medical Care Holdings, Inc. / 32,592 bags | Class II | Terminated |
| D-1035-2020 | 03-04-2020 | PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31 Package NDCs: 0603-5335-21; 0603-5335-32; 0603-5336-21; 0603-5337-21; 0603-5337-32; 0603-5337-15; 0603-5337-31; 0603-5338-21; 0603-5338-28; 0603-5338-32; 0603-5338-15; 0603-5338-31; 0603-5339-21; 0603-5339-28; 0603-5339-32 | Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg | Par Pharmaceutical Inc. / 13008 bottles | Class III | Terminated |
| D-1251-2020 | 03-03-2020 | PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 84124, e) Trust Company Oklahoma, trustok.com, f) Creekside Dental, www.creeksidedentalkennewick.com, g) Children's Healthcare of Atlanta Hughes Spalding, h) Great Smiles Orthodontics, Dr. Savage & Dr. Weissman, Crestline. Inverness.Turssville, www.bracebygreatsmiles.com, i) Acceleration station, j) The Children's Therapy & Learning Center, www.childrenstlc.com. FLAVORED LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as a) Gregory P. Miller DDS FAGD, 1140 South Avenue North Mankato, MN 56003, www.gregmillerdds.com, b) Shelby, c) Carolina Custom Traders, Wake Forest, North Carolina, c) Palm Springs Dental Associates Jonathan W. Preble, DMD, 499 E. Central Parkway, Suite 200, Altamonte Springs, FL 32701, www.drjpreble.com. LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as Family Dental of Thronton, 12889 Quebec St, Thornton, CO 80602, www.FamilyDentalofThornton.com. | Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone. | Yusef Manufacturing Laboratories, LLC / 12,983 tubes | Class II | Terminated |
| D-1042-2020 | 03-02-2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5552-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 9513 boxes | Class II | Terminated |
| D-1043-2020 | 03-02-2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5553-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 13761 boxes | Class II | Terminated |
| D-1044-2020 | 03-02-2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5554-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 11093 boxes | Class II | Terminated |
| D-0998-2020 | 03-02-2020 | Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01 | Product Mix-Up: A foreign tablet was found in bottle. | Mayne Pharma Inc / 8274 100-count bottles | Class II | Terminated |
| D-1045-2020 | 03-02-2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5555-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Noven Therapeutics, LLC / 7469 boxes | Class II | Terminated |
| D-0997-2020 | 02-28-2020 | Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01 | cGMP Deviation | Sunstar Guangzhou Ltd. / 260,000 tubes | Class II | Terminated |
| D-1001-2020 | 02-27-2020 | Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6803-61 Package NDCs: 0904-6801-61; 0904-6802-61; 0904-6803-61; 0904-6804-61; 0904-6805-61 | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. | The Harvard Drug Group / 115 cartons | Class III | Terminated |
| D-0995-2020 | 02-27-2020 | Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01 Package NDCs: 0069-0106-01 | Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button. | Pfizer Inc. / 24,714 vials | Class II | Terminated |
| D-1000-2020 | 02-27-2020 | Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6802-61 Package NDCs: 0904-6801-61; 0904-6802-61; 0904-6803-61; 0904-6804-61; 0904-6805-61 | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. | The Harvard Drug Group / 1 carton | Class III | Terminated |
| D-0999-2020 | 02-27-2020 | Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61 Package NDCs: 0904-6801-61; 0904-6802-61; 0904-6803-61; 0904-6804-61; 0904-6805-61 | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. | The Harvard Drug Group / 330 cartons | Class III | Terminated |
| D-1002-2020 | 02-27-2020 | Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6804-61 Package NDCs: 0904-6801-61; 0904-6802-61; 0904-6803-61; 0904-6804-61; 0904-6805-61 | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. | The Harvard Drug Group / | Class III | Terminated |
| D-1010-2020 | 02-24-2020 | Vancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 | Lack Of Processing Controls | Redline Pharmacy Solutions / 3 doses | Class II | Terminated |
| D-1009-2020 | 02-24-2020 | Ertapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 | Lack Of Processing Controls | Redline Pharmacy Solutions / 8 doses | Class II | Terminated |
| D-1007-2020 | 02-24-2020 | Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 | Lack Of Processing Controls | Redline Pharmacy Solutions / 1 20 ml syringe | Class II | Terminated |
| D-1006-2020 | 02-24-2020 | Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 | Lack Of Processing Controls | Redline Pharmacy Solutions / 2x5 ml bottles | Class II | Terminated |
| D-1008-2020 | 02-24-2020 | Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 | Lack Of Processing Controls | Redline Pharmacy Solutions / 16 doses | Class II | Terminated |
| D-1011-2020 | 02-24-2020 | Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 | Lack Of Processing Controls | Redline Pharmacy Solutions / 1 40 ml syringe | Class II | Terminated |
| D-1063-2020 | 02-24-2020 | Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98. | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing. | Breckenridge Pharmaceutical, Inc / 900 Vials | Class III | Terminated |
| D-0860-2020 | 02-21-2020 | Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00. | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube. | Akorn, Inc. / 24 tubes | Class III | Terminated |
| D-0861-2020 | 02-21-2020 | CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01 | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube. | Akorn, Inc. / N/A | Class III | Terminated |
| D-0859-2020 | 02-21-2020 | Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35 | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube. | Akorn, Inc. / 720 tubes | Class III | Terminated |
| D-0862-2020 | 02-20-2020 | Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22. Package NDCs: 0591-2245-22 | Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing. | Teva Pharmaceuticals USA / 3,695 bottles | Class II | Terminated |
| D-0866-2020 | 02-19-2020 | Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD | Failed Impurities/Degradation Specification; high out of specification results observed | Lupin Pharmaceuticals Inc. / 876 bottles | Class II | Terminated |
| D-1029-2020 | 02-17-2020 | Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08 Package NDCs: 64380-860-06; 64380-860-07; 64380-860-08; 64380-861-06; 64380-861-07; 64380-861-08 | Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg. | Strides Pharma Science Limited / 2576 bottles | Class III | Terminated |
| D-0868-2020 | 02-14-2020 | Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bottle, NDC 53943-192-06, UPC Code 0-93351-03070-3, Distributed by: Drug Mart -Food Fair, 211 Commerce Drive, Medina, OH 44256. | Labeling: Incorrect or Missing Lot and/or Expiration date. | AAA Pharmaceutical, Inc. / 3456 Bottles | Class III | Terminated |
| D-0856-2020 | 02-12-2020 | TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012 | Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet. | Golden State Medical Supply Inc. / 379,043 100-ct bottles and 330,997 500-ct bottles | Class III | Terminated |
| D-0855-2020 | 02-12-2020 | Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06 Package NDCs: 68180-246-06; 68180-249-06; 68180-249-09; 68180-249-02; 68180-247-06; 68180-247-09; 68180-248-06 | Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study. | Lupin Pharmaceuticals Inc. / 6,294 bottles | Class II | Terminated |
| D-0843-2020 | 02-10-2020 | Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34. | Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022. | Par Pharmaceutical Inc. / 9,936 cartons | Class III | Terminated |
| D-0863-2020 | 02-07-2020 | Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1 Package NDCs: 51672-4069-1; 51672-4069-2 | Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions. | Taro Pharmaceuticals U.S.A., Inc. / 29,172 8 Fl Oz bottles | Class I | Terminated |
| D-0852-2020 | 02-07-2020 | Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20 | Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie | AuroMedics Pharma LLC / 30432 bottles | Class II | Terminated |
| D-0853-2020 | 02-07-2020 | Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ, 08520, Made in India, NDC 55150-295-20. Package NDCs: 55150-292-01; 55150-293-02; 55150-294-05; 55150-295-20 | Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples). | AuroMedics Pharma LLC / 4600 Vials | Class III | Terminated |
| D-0848-2020 | 02-07-2020 | Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-606-21; NDC Unit Dose 68084-606-11 | GMP Deviations: Product bottle may be absent of desiccant. | American Health Packaging / 1,879 cartons | Class II | Terminated |
| D-0849-2020 | 02-07-2020 | Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-604-11 | GMP Deviations: Product bottle may be absent of desiccant. | American Health Packaging / 3,720 cartons | Class II | Terminated |
| D-0841-2020 | 02-05-2020 | Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30. Package NDCs: 0069-2150-30; 0069-2170-30; 0069-2190-30; 0069-2260-30; 0069-2160-30; 0069-2180-30; 0069-2250-30; 0069-2270-30; 0069-6180-30; 0069-6323-30; 0069-6565-30; 0069-6747-30; 0069-7810-30; 0069-7232-30; 0069-7654-30; 0069-7476-30 | Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection. | Pfizer Inc. / 141 bottles | Class II | Terminated |
| D-0842-2020 | 02-05-2020 | Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30. Package NDCs: 0069-2150-30; 0069-2170-30; 0069-2190-30; 0069-2260-30; 0069-2160-30; 0069-2180-30; 0069-2250-30; 0069-2270-30; 0069-6180-30; 0069-6323-30; 0069-6565-30; 0069-6747-30; 0069-7810-30; 0069-7232-30; 0069-7654-30; 0069-7476-30 | Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection. | Pfizer Inc. / 128 bottles | Class II | Terminated |
| D-0858-2020 | 02-03-2020 | Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60; UPC 3 09046 73060 6) and b) 1000-count bottles (NDC 0904-6730-80; UPC 3 09046 73080 4) Distributed by Major Pharmaceuticals 17177 N. Laurel Park Drive, Suite 233 Livonia, MI 45162 USA Package NDCs: 0904-6730-60; 0904-6730-80; 0904-6730-59; 0904-6730-61 | Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle. | Contract Pharmacal Corporation / a) 1176 bottles b) 6,216 bottles | Class II | Terminated |
| D-0857-2020 | 02-03-2020 | Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health, Dublin OHIO 43017 NDC 7000-0036-1, UPC 0 96295 13807 8 | Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle. | Contract Pharmacal Corporation / 5472 bottles | Class II | Terminated |
| D-0835-2020 | 02-03-2020 | Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray). | Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility. | Pfizer Inc. / 38,676 trays | Class II | Terminated |
| D-0846-2020 | 01-31-2020 | Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / 5387 6 Fl Oz bottles | Class II | Terminated |
| D-0845-2020 | 01-31-2020 | Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / 5249 6 Fl Oz bottles | Class II | Terminated |
| D-0847-2020 | 01-31-2020 | New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / 4080 8 FL Oz bottles | Class II | Terminated |
| D-0834-2020 | 01-31-2020 | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01. | cGMP Deviations | Zydus Pharmaceuticals USA Inc / 2207 Vials | Class II | Terminated |
| D-0829-2020 | 01-29-2020 | Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, Goa 403 511 India. Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816. NDC 29300-135-01 Package NDCs: 29300-468-05; 29300-468-10; 29300-468-50; 29300-468-01; 29300-136-01; 29300-136-05; 29300-136-10; 29300-136-50; 29300-137-01; 29300-137-05; 29300-137-10; 29300-137-25; 29300-135-01; 29300-135-05; 29300-135-10; 29300-135-50 | Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label. | UNICHEM PHARMACEUTICALS USA INC / 19161600 units | Class III | Terminated |
| D-0851-2020 | 01-28-2020 | Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545 | Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet. | Teva Pharmaceuticals USA / 2,044,497 bottles | Class III | Terminated |
| D-0832-2020 | 01-28-2020 | Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11. | Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg. | Graviti Pharmaceuticals Private Limited / 29,056 bottles | Class II | Terminated |
| D-0850-2020 | 01-28-2020 | Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39. | Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity. | NCS Healthcare of Kentucky Inc / 6929 blister cards | Class II | Terminated |
| D-0840-2020 | 01-28-2020 | Kushim Tablets (Gushim) 45-count packages, Label in foreign language | Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine | B AND A TRADING CORPORATION / 40 packages | Class II | Terminated |
| D-0837-2020 | 01-27-2020 | Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01 Package NDCs: 62037-725-01; 62037-734-01; 62037-726-01; 62037-727-01 | CGMP deviations: Product bottle may be absent of desiccant. | Teva Pharmaceuticals USA / 17,436 bottles | Class II | Terminated |
| D-0836-2020 | 01-27-2020 | Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01 Package NDCs: 62037-725-01; 62037-734-01; 62037-726-01; 62037-727-01 | CGMP deviations: Product bottle may be absent of desiccant. | Teva Pharmaceuticals USA / | Class II | Terminated |
| D-0831-2020 | 01-27-2020 | Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01 | GMP Deviations: Product bottle may be absent of desiccant. | Teva Pharmaceuticals USA / 69,012 bottles | Class II | Terminated |
