| Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25 |
Hikma Injectables USA Inc |
Class I |
Completed |
20240529 |
| Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01 |
American Regent, Inc. |
Class II |
Terminated |
20240529 |
| Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India. |
SOMERSET THERAPEUTICS LLC |
Class II |
Ongoing |
20240529 |
| Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03 |
Preferred Pharmaceuticals, Inc. |
Class II |
Ongoing |
20240529 |
| Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01 |
Dr. Reddy's Laboratories, Inc. |
Class III |
Ongoing |
20240529 |
| niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10 |
American Regent, Inc. |
Class II |
Terminated |
20240529 |
| Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90 |
SUN PHARMACEUTICAL INDUSTRIES INC |
Class III |
Ongoing |
20240529 |
| Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9 |
Pharma Nobis LLC |
Class II |
Ongoing |
20240522 |
| CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10. |
Pharma Nobis LLC |
Class II |
Ongoing |
20240522 |
| MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10 |
Sagent Pharmaceuticals |
Class II |
Ongoing |
20240522 |
| Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44 |
MACLEODS PHARMA USA, INC |
Class II |
Ongoing |
20240522 |
| Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04 |
Lupin Pharmaceuticals Inc. |
Class II |
Terminated |
20240522 |
| Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04 |
Lupin Pharmaceuticals Inc. |
Class II |
Terminated |
20240522 |
| Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01 |
Dercher Enterprises, Inc., DBA Gordon Laboratories |
Class II |
Completed |
20240522 |
| Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV. |
Stop Clopez Corp |
Class I |
Terminated |
20240522 |
| Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01 |
SUN PHARMACEUTICAL INDUSTRIES INC |
Class II |
Ongoing |
20240515 |
| Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. |
Aurobindo Pharma USA Inc. |
Class II |
Ongoing |
20240515 |
| Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. |
Aurobindo Pharma USA Inc. |
Class II |
Ongoing |
20240515 |
| Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06 |
Acella Pharmaceuticals, LLC |
Class III |
Terminated |
20240515 |
| TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762 |
RemedyRepack Inc. |
Class II |
Terminated |
20240515 |
| Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ |
FDC Limited |
Class II |
Terminated |
20240515 |
| traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00 |
Rubicon Research Private Limited |
Class II |
Ongoing |
20240515 |
| Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30. |
Dr. Reddy's Laboratories, Inc. |
Class I |
Ongoing |
20240515 |
| Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30. |
Dr. Reddy's Laboratories, Inc. |
Class I |
Ongoing |
20240515 |
| Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90. |
Breckenridge Pharmaceutical, Inc |
Class II |
Ongoing |
20240515 |
| Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05. |
Breckenridge Pharmaceutical, Inc |
Class II |
Ongoing |
20240515 |
| Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. |
Breckenridge Pharmaceutical, Inc |
Class II |
Ongoing |
20240515 |
| Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77 |
Viatris Inc |
Class III |
Completed |
20240508 |
| Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05 |
Hikma Injectables USA Inc |
Class III |
Completed |
20240508 |
| EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01 |
Regeneron Pharmaceuticals Inc |
Class II |
Terminated |
20240508 |
| Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01 |
Imprimis NJOF, LLC |
Class III |
Ongoing |
20240508 |
| Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2. |
Amneal Pharmaceuticals of New York, LLC |
Class II |
Completed |
20240508 |
| Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08 |
Imprimis NJOF, LLC |
Class II |
Ongoing |
20240508 |
| minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30. |
EPI Health, LLC |
Class II |
Terminated |
20240501 |
| minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30. |
EPI Health, LLC |
Class II |
Terminated |
20240501 |
| Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90 |
EPI Health, LLC |
Class II |
Terminated |
20240501 |
| Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01. |
Glenmark Pharmaceuticals Inc., USA |
Class II |
Ongoing |
20240501 |
| Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53 |
Cipla USA, Inc. |
Class II |
Terminated |
20240501 |
| ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card. |
FA Online Inc |
Class I |
Terminated |
20240501 |
| Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13 |
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. |
Class III |
Ongoing |
20240501 |
| Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13 |
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. |
Class III |
Ongoing |
20240501 |
| Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc. |
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. |
Class III |
Ongoing |
20240501 |
| Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13 |
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. |
Class III |
Ongoing |
20240501 |
| FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01. |
Nomax Inc |
Class II |
Ongoing |
20240501 |
| FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03. |
Nomax Inc |
Class II |
Ongoing |
20240501 |
| GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40. |
Nomax Inc |
Class II |
Ongoing |
20240501 |
| GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123. |
Nomax Inc |
Class II |
Ongoing |
20240501 |
| Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37 |
HONEYWELL INC |
Class II |
Terminated |
20240501 |
| Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5 |
Aruba Aloe Balm N.V. |
Class I |
Ongoing |
20240501 |
| Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. |
Aruba Aloe Balm N.V. |
Class I |
Ongoing |
20240501 |