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 May 24, 2024 and include a total of 16208 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0498-2024 | 05-07-2024 | 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 Package NDCs: 33342-050-07; 33342-050-10; 33342-050-44; 33342-050-12; 33342-051-07; 33342-051-10; 33342-051-44; 33342-051-12; 33342-052-07; 33342-052-10; 33342-052-44; 33342-052-12 | Presence of foreign substance: plastic-like substance. | MACLEODS PHARMA USA, INC / 1,048 bottles | Class II | Ongoing |
| D-0500-2024 | 05-01-2024 | 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. Package NDCs: 51316-881-10 | Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria | Pharma Nobis LLC / 120830 | Class II | Ongoing |
| D-0501-2024 | 05-01-2024 | 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 Package NDCs: 79481-0034-9 | Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria | Pharma Nobis LLC / 24840 | Class II | Ongoing |
| D-0480-2024 | 04-30-2024 | 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 | Labeling: Wrong Barcode | Hikma Injectables USA Inc / 1,895 bags | Class III | Ongoing |
| D-0482-2024 | 04-29-2024 | 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. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. | Breckenridge Pharmaceutical, Inc / 281,554/90 & 1000 count bottles | Class II | Ongoing |
| D-0483-2024 | 04-29-2024 | 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. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. | Breckenridge Pharmaceutical, Inc / 7,188/ 500 count bottles | Class II | Ongoing |
| D-0484-2024 | 04-29-2024 | 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. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. | Breckenridge Pharmaceutical, Inc / 281,554/90 count bottles | Class II | Ongoing |
| D-0487-2024 | 04-26-2024 | 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 Package NDCs: 72888-162-30; 72888-162-01; 72888-162-05; 72888-162-00; 72888-080-01; 72888-080-05; 72888-080-00; 72888-008-01; 72888-008-05; 72888-008-00 | Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol | Rubicon Research Private Limited / 2,592 1000-count Bottles | Class II | Ongoing |
| D-0488-2024 | 04-25-2024 | 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 Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15 | Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers. | FDC Limited / 382,104 units | Class II | Ongoing |
| D-0499-2024 | 04-25-2024 | 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 Package NDCs: 25021-820-05; 25021-820-10; 25021-821-05 | Presence of Particulate Matter: Potential for black particulates in the drug product. | Sagent Pharmaceuticals / 14,360 vials | Class II | Ongoing |
| D-0481-2024 | 04-25-2024 | Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77 Package NDCs: 0378-4275-93; 0378-4275-77; 0378-4276-93; 0378-4276-77 | Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets. | Viatris Inc / 143,230 bottles | Class III | Ongoing |
| D-0490-2024 | 04-24-2024 | 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 Package NDCs: 42192-136-06; 42192-136-08; 42192-136-12 | Subpotent drug | Acella Pharmaceuticals, LLC / 7104 Bottles | Class III | Ongoing |
| D-0492-2024 | 04-24-2024 | 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. Package NDCs: 13107-282-01; 13107-282-05; 13107-283-01; 13107-283-05; 13107-284-01 | Discoloration: Dotted and yellow spots on tablets | Aurobindo Pharma USA Inc. / 6909 bottles | Class II | Ongoing |
| D-0491-2024 | 04-24-2024 | 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. Package NDCs: 13107-282-01; 13107-282-05; 13107-283-01; 13107-283-05; 13107-284-01 | Discoloration: Dotted and yellow spots on tablets | Aurobindo Pharma USA Inc. / 6696 bottles | Class II | Ongoing |
| D-0496-2024 | 04-24-2024 | 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 Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. | Lupin Pharmaceuticals Inc. / 17,070 bottles | Class II | Ongoing |
| D-0497-2024 | 04-24-2024 | 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 Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. | Lupin Pharmaceuticals Inc. / 17,040 bottles | Class II | Ongoing |
| D-0474-2024 | 04-23-2024 | 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. | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. | EPI Health, LLC / 12808 bottles | Class II | Ongoing |
| D-0475-2024 | 04-23-2024 | 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. | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. | EPI Health, LLC / 5664 bottles | Class II | Ongoing |
| D-0473-2024 | 04-23-2024 | 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 | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. | EPI Health, LLC / 18645 tubes | Class II | Ongoing |
| D-0479-2024 | 04-23-2024 | 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 Package NDCs: 61755-005-02; 61755-005-55; 61755-005-01; 61755-005-54; 8231500321; 8231500335; 8231500333; 8231500334; 8231500339; 8231500347 | Lack of Assurance of Sterility: Complaints of syringe breakage | Regeneron Pharmaceuticals Inc / 251,504 syringes | Class II | Ongoing |
| D-0494-2024 | 04-22-2024 | Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV. | Marketed Without An Approved NDA/ANDA | Stop Clopez Corp / 5 boxes | Class I | Ongoing |
| D-0493-2024 | 04-19-2024 | 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 Package NDCs: 62756-233-01; 62756-233-02 | Out of specification for assay | SUN PHARMACEUTICAL INDUSTRIES INC / 11,016 vials | Class II | Ongoing |
| D-0463-2024 | 04-19-2024 | 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. Package NDCs: 51801-009-50; 51801-009-40 | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities. | Nomax Inc / 6,960 cartons | Class II | Ongoing |
| D-0464-2024 | 04-19-2024 | 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. | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities. | Nomax Inc / 4648 cartons | Class II | Ongoing |
| D-0462-2024 | 04-19-2024 | 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. Package NDCs: 51801-003-50; 51801-003-40 | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities. | Nomax Inc / 15,056 cartons | Class II | Ongoing |
| D-0465-2024 | 04-19-2024 | 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. | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities. | Nomax Inc / 15,444 cartons | Class II | Ongoing |
| D-0472-2024 | 04-17-2024 | 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. Package NDCs: 68462-850-01; 68462-851-01; 68462-562-01 | Failed Dissolution Specifications | Glenmark Pharmaceuticals Inc., USA / 3,264 bottles | Class II | Ongoing |
| D-0495-2024 | 04-12-2024 | Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01 | cGMP Deviations | Dercher Enterprises, Inc., DBA Gordon Laboratories / 5,247 glass jars | Class II | Ongoing |
| D-0476-2024 | 04-10-2024 | 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 | Subpotent Drug | Imprimis NJOF, LLC / 3320 bottles | Class II | Ongoing |
| D-0478-2024 | 04-10-2024 | 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 | Out of specification for assay | Imprimis NJOF, LLC / 15,414 units | Class III | Ongoing |
| D-0467-2024 | 04-09-2024 | 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. Package NDCs: 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35; 59148-013-15; 59148-640-23; 59148-641-23; 59148-016-65 | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. / N/A | Class III | Ongoing |
| D-0468-2024 | 04-09-2024 | Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13 Package NDCs: 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35; 59148-013-15; 59148-640-23; 59148-641-23; 59148-016-65 | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. / N/A | Class III | Ongoing |
| D-0469-2024 | 04-09-2024 | Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13 Package NDCs: 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35; 59148-013-15; 59148-640-23; 59148-641-23; 59148-016-65 | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. / N/A | Class III | Ongoing |
| D-0466-2024 | 04-09-2024 | Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13 Package NDCs: 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35; 59148-013-15; 59148-640-23; 59148-641-23; 59148-016-65 | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. / 108,192/30 count bottles or 7 count blister packs | Class III | Ongoing |
| D-0485-2024 | 04-08-2024 | 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. Package NDCs: 43598-097-11; 43598-097-30 | Sub-potent Drug; powder discoloration associated with decreased potency | Dr. Reddy's Laboratories, Inc. / 17,332 cartons | Class I | Ongoing |
| D-0486-2024 | 04-08-2024 | 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. Package NDCs: 43598-477-11; 43598-477-30 | Sub-potent Drug; powder discoloration associated with decreased potency | Dr. Reddy's Laboratories, Inc. / 2402 cartons | Class I | Ongoing |
| D-0434-2024 | 04-02-2024 | Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01. | Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'. | X-Gen Pharmaceuticals Inc. / 1332 vials | Class III | Ongoing |
| D-0433-2024 | 04-02-2024 | Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01. | Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'. | X-Gen Pharmaceuticals Inc. / 1283 vials | Class III | Ongoing |
| D-0461-2024 | 03-29-2024 | 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 Package NDCs: 0498-0631-37 | CGMP Deviations | HONEYWELL INC / 10, 605 cartridges | Class II | Ongoing |
| D-0439-2024 | 03-28-2024 | Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15 Package NDCs: 0591-2433-45; 0591-2433-15; 0591-2434-45; 0591-2434-15; 0591-2451-45; 0591-2451-15; 0591-2435-45; 0591-2435-15; 0591-2501-45; 0591-2501-15; 0591-2436-45; 0591-2436-15 | Superpotent Drug: The 3-month stability result for assay was found to be above specification limit | Teva Pharmaceuticals USA, Inc / 5,304 3x10-cartons | Class II | Ongoing |
| D-0444-2024 | 03-28-2024 | Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12. Package NDCs: 50268-086-11; 50268-086-12 | Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. | AvKARE / 153 cartons | Class I | Ongoing |
| D-0441-2024 | 03-27-2024 | NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03 Package NDCs: 72426-818-03; 72426-818-09; 72426-818-99 | Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint. | Esperion / 3,480 30-count bottles | Class III | Ongoing |
| D-0438-2024 | 03-27-2024 | Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41 | CGMP Deviations | NATCO Pharma Limited / 30 bottles | Class II | Ongoing |
| D-0471-2024 | 03-26-2024 | 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 Package NDCs: 69097-173-64; 69097-173-53 | Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch. | Cipla USA, Inc. / 59244/3ml FFS packs | Class II | Ongoing |
| D-0430-2024 | 03-26-2024 | 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 Package NDCs: 68462-850-01; 68462-851-01; 68462-562-01 | Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study. | Glenmark Pharmaceuticals Inc., USA / 6,528 bottles | Class II | Ongoing |
| D-0477-2024 | 03-25-2024 | Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2. | Failed Dissolution Specifications | Amneal Pharmaceuticals of New York, LLC / 2784 bottles | Class II | Ongoing |
| D-0443-2024 | 03-25-2024 | Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10 Package NDCs: 70954-201-10; 70954-201-20; 70954-202-10; 70954-202-20; 70954-200-10 | Failed Impurities/Degradation Specifications | Novitium Pharma LLC / 1,003 bottles | Class III | Ongoing |
| D-0459-2024 | 03-23-2024 | 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. | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Aruba Aloe Balm N.V. / 9,625 bottles | Class I | Ongoing |
| D-0460-2024 | 03-23-2024 | 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 | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Aruba Aloe Balm N.V. / 5299 bottles | Class I | Ongoing |
| D-0432-2024 | 03-22-2024 | fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1 | Lack of Assurance of Sterility: leaking bags | IntegraDose Compounding Services LLC / 187 cassettes | Class II | Ongoing |
| D-0431-2024 | 03-22-2024 | Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00 Package NDCs: 0264-7750-00; 0264-7750-10; 0264-7750-20 | Lack of assurance of sterility: bags have the potential to leak.. | B. Braun Medical Inc / 7,800 bags | Class II | Ongoing |
| D-0437-2024 | 03-21-2024 | Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06 | Subpotent Drug | Lupin Pharmaceuticals Inc. / 26,352 bottles | Class II | Ongoing |
| D-0442-2024 | 03-21-2024 | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 Package NDCs: 69238-2261-3; 69238-2261-7; 69238-2261-5 | Superpotent Drug: Due to overfilling of drug powder | Amneal Pharmaceuticals of New York, LLC / 821 bottles | Class I | Ongoing |
| D-0427-2024 | 03-21-2024 | VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01 Package NDCs: 52925-112-01 | cGMP Diviations | Apothecus Pharmaceutical Corp. / 17,280 paper cartons | Class II | Ongoing |
| D-0456-2024 | 03-19-2024 | The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 10 boxes | Class I | Ongoing |
| D-0455-2024 | 03-19-2024 | SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 7 pieces | Class I | Ongoing |
| D-0457-2024 | 03-19-2024 | ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 4,351 pieces | Class I | Ongoing |
| D-0451-2024 | 03-19-2024 | Samurai-X Honey 6800, UPC 2 56891 27553 3. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / N/A | Class I | Ongoing |
| D-0453-2024 | 03-19-2024 | GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 12 boxes | Class I | Ongoing |
| D-0449-2024 | 03-19-2024 | Weiner Boner Honey, 12g packet, 100% Organic Formula. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 19 boxes | Class I | Ongoing |
| D-0458-2024 | 03-19-2024 | HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 19 boxes | Class I | Ongoing |
| D-0454-2024 | 03-19-2024 | libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 7 boxes | Class I | Ongoing |
| D-0448-2024 | 03-19-2024 | Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 45 boxes | Class I | Ongoing |
| D-0452-2024 | 03-19-2024 | Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 149 boxes | Class I | Ongoing |
| D-0450-2024 | 03-19-2024 | Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / N/A | Class I | Ongoing |
| D-0445-2024 | 03-12-2024 | Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01 Package NDCs: 0002-8315-01; 0002-8315-17; 0002-8315-99; 0002-8805-01; 0002-8805-59; 0002-8805-99; 0002-0800-01 | CGMP Deviations | Eli Lilly & Company / 700 vials | Class II | Ongoing |
| D-0392-2024 | 03-12-2024 | Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01 Package NDCs: 0641-6039-01; 0641-6040-01 | The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot. | Hikma Pharmaceuticals USA Inc. / 22,644 ampuls | Class II | Ongoing |
| D-0428-2024 | 03-07-2024 | Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62 Package NDCs: 0093-2140-28; 0093-2140-62 | Failed Dissolution Specifications | Teva Pharmaceuticals USA, Inc / 92,676 cartons | Class II | Ongoing |
| D-0370-2024 | 03-06-2024 | Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20 Package NDCs: 0264-1944-20 | Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks. | B. Braun Medical Inc / 22,752 bags | Class II | Ongoing |
| D-0374-2024 | 03-05-2024 | Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15 Package NDCs: 82584-001-05; 82584-002-05; 82584-002-15 | Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. | Thea Pharma, Inc. / 5,476 bottles | Class II | Ongoing |
| D-0429-2024 | 03-04-2024 | Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01 Package NDCs: 42023-209-01; 42023-208-01; 42023-207-01; 42023-206-01 | Presence of Particulate Matter. | Par Sterile Products LLC / 466 vials | Class I | Ongoing |
| D-0369-2024 | 03-04-2024 | Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01. Package NDCs: 16714-059-01; 16714-060-01 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 7,488 bottles | Class II | Ongoing |
| D-0368-2024 | 03-04-2024 | Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01. Package NDCs: 16714-059-01; 16714-060-01 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 47,520 bottles | Class II | Ongoing |
| D-0389-2024 | 03-04-2024 | Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20 Package NDCs: 70954-201-10; 70954-201-20; 70954-202-10; 70954-202-20; 70954-200-10 | Cross Contamination with Other Products:(mycophenolate mofetil). | Novitium Pharma LLC / 3,940 1000-count bottles | Class III | Ongoing |
| D-0446-2024 | 03-01-2024 | S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01. | Failed Stability Specifications | Specialty Process Labs LLC / 26 units | Class II | Ongoing |
| D-0447-2024 | 03-01-2024 | S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03 | Failed Stability Specifications | Specialty Process Labs LLC / 217 units | Class II | Ongoing |
| D-0436-2024 | 02-29-2024 | FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1 | Lack of Assurance of Sterility: Firm did not perform process validation. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / 140 vials | Class II | Ongoing |
| D-0435-2024 | 02-29-2024 | Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1 | Lack of Assurance of Sterility: Firm did not perform process validation. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / 11,798 syringes | Class II | Ongoing |
| D-0376-2024 | 02-29-2024 | TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11. Package NDCs: 17312-002-11 | Lack of Assurance of Sterility | Optikem International, Inc. / 7,248 bottles | Class II | Ongoing |
| D-0375-2024 | 02-29-2024 | TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15. Package NDCs: 17312-032-15; 17312-032-99 | Lack of Assurance of Sterility | Optikem International, Inc. / 30,240 bottles | Class II | Ongoing |
| D-0383-2024 | 02-29-2024 | TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15. | Lack of Assurance of Sterility | Optikem International, Inc. / 106,704 bottles | Class II | Ongoing |
| D-0377-2024 | 02-29-2024 | TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15. Package NDCs: 17312-040-15 | Lack of Assurance of Sterility | Optikem International, Inc. / 9,936 bottles | Class II | Ongoing |
| D-0381-2024 | 02-29-2024 | TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15. Package NDCs: 17312-027-15 | Lack of Assurance of Sterility | Optikem International, Inc. / 19,344 bottles | Class II | Ongoing |
| D-0384-2024 | 02-29-2024 | hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150 | Lack of Assurance of Sterility | Optikem International, Inc. / 46,621 bottles | Class II | Ongoing |
| D-0379-2024 | 02-29-2024 | TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15. Package NDCs: 17312-172-15 | Lack of Assurance of Sterility | Optikem International, Inc. / 10,536 bottles | Class II | Ongoing |
| D-0380-2024 | 02-29-2024 | TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15. Package NDCs: 17312-098-15 | Lack of Assurance of Sterility | Optikem International, Inc. / 24,216 bottles | Class II | Ongoing |
| D-0378-2024 | 02-29-2024 | TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15. Package NDCs: 17312-178-15; 17312-178-99 | Lack of Assurance of Sterility | Optikem International, Inc. / 47,832 bottles | Class II | Ongoing |
| D-0382-2024 | 02-29-2024 | TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15. Package NDCs: 17312-013-15; 17312-013-99 | Lack of Assurance of Sterility | Optikem International, Inc. / 139,656 bottles | Class II | Ongoing |
| D-0385-2024 | 02-22-2024 | Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01. Package NDCs: 55150-470-01; 55150-470-06 | Failed Stability Specification: Water determination was found not complying with specification. | Eugia US LLC / 1160 VIALS | Class II | Ongoing |
| D-0364-2024 | 02-20-2024 | Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61 | Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint. | Contract Pharmaceuticals Limited Canada / 45,875 bottles | Class III | Ongoing |
| D-0365-2024 | 02-20-2024 | Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60 | Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint. | Contract Pharmaceuticals Limited Canada / 11,750 bottles | Class III | Ongoing |
| D-0391-2024 | 02-20-2024 | Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11 Package NDCs: 55150-183-02; 55150-183-11 | Failed Impurities/Degradation Specifications: Out of specification for organic impurities | Eugia US LLC / 43,920 vials | Class II | Ongoing |
| D-0366-2024 | 02-20-2024 | Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01 Package NDCs: 55150-313-25; 55150-313-01; 55150-314-25; 55150-314-01 | Failed Dissolution Specifications | Eugia US LLC / 10,080 vials | Class II | Ongoing |
| D-0363-2024 | 02-20-2024 | Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42 | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. | Denver Solutions, LLC DBA Leiters Health / 40,890 vials | Class II | Ongoing |
| D-0361-2024 | 02-20-2024 | Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42 | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. | Denver Solutions, LLC DBA Leiters Health / 40,090 vials | Class II | Ongoing |
| D-0362-2024 | 02-20-2024 | Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42 | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. | Denver Solutions, LLC DBA Leiters Health / 10,020 vials | Class II | Ongoing |
| D-0390-2024 | 02-20-2024 | Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10 Package NDCs: 55150-183-01; 55150-183-10 | Failed Impurities/Degradation Specifications: Out of specification for organic impurities | Eugia US LLC / 335,940 vials | Class II | Ongoing |
| D-0356-2024 | 02-19-2024 | PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471. | CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. | Seatex LLC / 1,450 cases | Class II | Ongoing |
| D-0357-2024 | 02-19-2024 | PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471 | CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. | Seatex LLC / 274 cases | Class II | Ongoing |
| D-0359-2024 | 02-19-2024 | 7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033 | CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. | Seatex LLC / 1,282 cases | Class II | Ongoing |