Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 08, 2025 and include a total of 16999 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0012-2023 | 10-06-2022 | Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC 51407-322-30 | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). | Golden State Medical Supply Inc. / N/A | Class II | Terminated |
| D-0011-2023 | 10-06-2022 | Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA. | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). | Golden State Medical Supply Inc. / N/A | Class II | Terminated |
| D-0021-2023 | 10-05-2022 | Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90 Package NDCs: 65862-161-90; 65862-162-30; 65862-162-90; 65862-163-90 | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. | Aurobindo Pharma USA Inc. / 9504 bottles | Class II | Completed |
| D-0023-2023 | 10-04-2022 | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1. Package NDCs: 72572-740-20; 72572-740-25 | Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration | Exela Pharma Sciences LLC / 148,920 | Class I | Completed |
| D-0022-2023 | 10-04-2022 | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1 Package NDCs: 51754-5001-5; 51754-5001-4; 51754-5011-4; 51754-5002-5; 51754-5012-4; 51754-5001-1 | Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration | Exela Pharma Sciences LLC / 2,123,040 vials | Class I | Completed |
| D-0010-2023 | 09-30-2022 | Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7 Package NDCs: 50742-317-25 | Out of specification for related substances (impurities). | Ingenus Pharmaceuticals Llc / 6176 bottles | Class II | Completed |
| D-0020-2023 | 09-30-2022 | Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe) Package NDCs: 55150-230-00; 55150-230-02; 55150-230-10; 55150-231-00; 55150-231-02; 55150-231-10; 55150-232-00; 55150-232-02; 55150-232-10; 55150-233-00; 55150-233-02; 55150-233-10 | Subpotent Drug: Out of specification for assay | AuroMedics Pharma LLC / 11,520 units | Class II | Terminated |
| D-0018-2023 | 09-30-2022 | Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01 Package NDCs: 66689-406-01; 66689-406-10 | cGMP Deviations: Out of specification for assay of one of the preservative ingredients. | VistaPharm, Inc. / 1980 cups | Class II | Terminated |
| D-1550-2022 | 09-29-2022 | Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. Package NDCs: 69097-168-48; 69097-168-87; 69097-168-64; 69097-168-32; 69097-168-53 | Lack of Assurance of Sterility: environmental monitoring failure. | CIPLA / 9041 cartons | Class II | Terminated |
| D-0019-2023 | 09-29-2022 | Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10 Package NDCs: 60429-027-90; 60429-027-10; 60429-025-90; 60429-025-10; 60429-026-90; 60429-026-10 | Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets | Golden State Medical Supply Inc. / 2,584 Bottles | Class I | Terminated |
| D-0003-2023 | 09-27-2022 | Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton) Package NDCs: 0409-5921-16; 0409-5921-01; 0409-5922-16; 0409-5922-01 | Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial. | Pfizer Inc. / 103,150 10 mL vials | Class II | Terminated |
| D-0013-2023 | 09-26-2022 | Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10. Package NDCs: 55150-154-10; 55150-155-20 | Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial. | AuroMedics Pharma LLC / 89400 vials | Class II | Completed |
| D-1551-2022 | 09-26-2022 | Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10 Package NDCs: 55150-188-10 | Presence of Particulate Matter: Piece of metal found in a vial | AuroMedics Pharma LLC / 88080 vials | Class III | Ongoing |
| D-1547-2022 | 09-21-2022 | Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30 | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). | Akorn, Inc. / 18,145 bottles | Class II | Ongoing |
| D-1542-2022 | 09-21-2022 | Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A | Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial. | Viatris Inc / 3,931 cartons | Class II | Terminated |
| D-1548-2022 | 09-21-2022 | Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031. | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). | Akorn, Inc. / 177,439 bottles | Class II | Ongoing |
| D-1544-2022 | 09-20-2022 | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07. | Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL). | QuVa Pharma, Inc. / 1994 bags | Class III | Terminated |
| D-1541-2022 | 09-19-2022 | Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, 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# 29300-137-01 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 | Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets, | UNICHEM PHARMACEUTICALS USA INC / 18,960 bottles of 100 | Class III | Terminated |
| D-1549-2022 | 09-16-2022 | Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45 | Failed Viscosity specification: Slightly higher OOS results obtained for viscosity | ALMIRALL, LLC / 5,315 tubes | Class III | Terminated |
| D-1543-2022 | 09-16-2022 | Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15. Package NDCs: 0078-0246-61; 0078-0246-15; 0078-0248-61; 0078-0248-15; 0078-0274-22 | CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content. | Novartis Pharmaceuticals Corporation / 132,999 cartons | Class II | Terminated |
| D-1545-2022 | 09-15-2022 | Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86. Package NDCs: 69097-318-86; 69097-318-87; 69097-318-32; 69097-318-53; 69097-319-86; 69097-319-87; 69097-319-32; 69097-319-53; 69097-321-86; 69097-321-87; 69097-321-32; 69097-321-53 | Lack of Assurance of Sterility | CIPLA / 641,160 ampules | Class II | Terminated |
| D-1538-2022 | 09-15-2022 | Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00 | Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. | RemedyRepack Inc. / 1,699 blister cards/30 tablets each | Class II | Terminated |
| D-0002-2023 | 09-14-2022 | Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles, Dist. By Antica Farmacista Seattle, WA 98122 UPC 8 47005 00450 9 | Chemical Contamination: product found to contain benzene | Salon Technologies International Inc / 512 bottles | Class I | Terminated |
| D-0001-2023 | 09-14-2022 | Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon Technologies International 8810 Commodity Circle STE 22-23, Orlando, FL 32819, UPC 6 96952 12904 5 | GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Salon Technologies International Inc / 1656 bottles | Class II | Terminated |
| D-0007-2023 | 09-14-2022 | Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16 Package NDCs: 43598-405-11; 43598-405-16 | Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content. | Dr. Reddy's Laboratories, Inc. / 2,838 ampules | Class III | Completed |
| D-1536-2022 | 09-13-2022 | Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03 Package NDCs: 68180-512-02; 68180-512-30; 68180-512-09; 68180-512-01; 68180-512-03; 68180-513-30; 68180-513-03; 68180-513-01; 68180-513-09; 68180-513-02; 68180-513-05; 68180-517-03; 68180-517-01; 68180-517-30; 68180-517-09; 68180-517-04; 68180-517-02; 68180-980-03; 68180-980-30; 68180-980-01; 68180-980-09; 68180-980-05; 68180-980-02; 68180-981-01; 68180-981-03; 68180-981-30; 68180-981-09; 68180-981-02; 68180-981-05; 68180-982-01; 68180-982-02; 68180-982-30; 68180-982-03; 68180-982-09; 68180-979-01; 68180-979-03; 68180-979-30; 68180-979-09; 68180-514-01; 68180-514-02; 68180-514-03; 68180-514-09; 68180-514-30; 68180-514-05; 68180-515-01; 68180-515-02; 68180-515-03; 68180-515-09; 68180-515-30; 68180-515-05; 68180-516-01; 68180-516-02; 68180-516-03; 68180-516-09; 68180-516-30 | Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. | Lupin Pharmaceuticals Inc. / 11,802 1000-count bottles | Class II | Terminated |
| D-1535-2022 | 09-12-2022 | Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80. Package NDCs: 72189-330-80 | CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. | Direct Rx / 20 tubes | Class II | Completed |
| D-0009-2023 | 09-09-2022 | Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8 | Marketed Without An Approved NDA/ANDA; Unapproved new drug | Justified Laboratories / Unknown | Class II | Terminated |
| D-0008-2023 | 09-09-2022 | Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53220 1 | Marketed Without An Approved NDA/ANDA; Unapproved new drug | Justified Laboratories / Unknown | Class II | Terminated |
| D-1537-2022 | 09-01-2022 | Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are not available, Alcohol 80% Topical Solution, Antiseptic, 8.5 oz./ 250 mL bottles, Made and Distributed by: Superior Glove Works Ltd., 36 Vimy Street, Acton, Ontario, L7J 1S1, Canada, Made in Canada, UPC: 779406201594. | CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits. | SUPERIOR GLOVE WORKS, LTD. / 7,296 bottles | Class II | Terminated |
| D-1495-2022 | 08-31-2022 | Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31 | cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause. | Akorn, Inc. / 82,689 tubes | Class II | Terminated |
| D-1496-2022 | 08-31-2022 | Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35 | cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause. | Akorn, Inc. / 48,636 tubes | Class II | Terminated |
| D-0006-2023 | 08-30-2022 | Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S, 800-323-2251, Made in USA, NDC 11429-1010-8 Package NDCs: 11429-1010-1; 11429-1010-7; 11429-1010-3; 11429-1010-8 | Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label. | Woodbine Products Co Inc / 595 cases (4 bottles per case) | Class III | Terminated |
| D-1539-2022 | 08-29-2022 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02. Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product. | Teva Pharmaceuticals USA Inc / 83,703 bottles | Class II | Terminated |
| D-1526-2022 | 08-26-2022 | TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 16 vials | Class II | Completed |
| D-1518-2022 | 08-26-2022 | Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 8 syringes | Class II | Completed |
| D-1515-2022 | 08-26-2022 | L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 1 vial | Class II | Completed |
| D-1521-2022 | 08-26-2022 | Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 4 syringes | Class II | Completed |
| D-1516-2022 | 08-26-2022 | MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 3 vials | Class II | Completed |
| D-1531-2022 | 08-26-2022 | TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 2 vials | Class II | Completed |
| D-1520-2022 | 08-26-2022 | Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 4 syringes | Class II | Completed |
| D-1517-2022 | 08-26-2022 | MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 4 vials | Class II | Completed |
| D-1524-2022 | 08-26-2022 | TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 348 vials | Class II | Completed |
| D-1533-2022 | 08-26-2022 | QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 1 vial | Class II | Completed |
| D-1528-2022 | 08-26-2022 | TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 2 vials | Class II | Completed |
| D-1522-2022 | 08-26-2022 | TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 2 vials | Class II | Completed |
| D-1519-2022 | 08-26-2022 | Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 24 syringes | Class II | Completed |
| D-1532-2022 | 08-26-2022 | TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 1 vial | Class II | Completed |
| D-1534-2022 | 08-26-2022 | QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 1 vial | Class II | Completed |
| D-1529-2022 | 08-26-2022 | TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 3 vials | Class II | Completed |
| D-1530-2022 | 08-26-2022 | TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 11 vials | Class II | Completed |
| D-1525-2022 | 08-26-2022 | TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 1 vial | Class II | Completed |
| D-1527-2022 | 08-26-2022 | TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 7 vials | Class II | Completed |
| D-1523-2022 | 08-26-2022 | TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 3 vials | Class II | Completed |
| D-1473-2022 | 08-23-2022 | Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01 Package NDCs: 0093-1177-01 | CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg. | Teva Pharmaceuticals USA Inc / | Class II | Terminated |
| D-1546-2022 | 08-23-2022 | ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01 Package NDCs: 69315-167-03; 69315-167-01; 69315-167-09; 69315-166-03; 69315-166-01; 69315-166-09; 69315-165-03; 69315-165-01 | Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules | Leading Pharma, LLC / 960 bottles (100 capsules) | Class III | Terminated |
| D-1540-2022 | 08-22-2022 | PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25 | Presence of particulate matter | Pfizer Inc. / 5,390 vials | Class I | Terminated |
| D-1499-2022 | 08-22-2022 | Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35. Package NDCs: 69097-341-35 | Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility. | CIPLA / 117,844 bottles | Class II | Terminated |
| D-1498-2022 | 08-22-2022 | Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50. | Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility. | CIPLA / 3,468 bottles | Class II | Terminated |
| D-1497-2022 | 08-17-2022 | Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36. Package NDCs: 45802-063-35; 45802-063-36; 45802-063-05; 45802-064-35; 45802-064-36; 45802-064-05; 45802-065-35 | CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. | Padagis US LLC / 57,816 tubes | Class II | Terminated |
| D-0016-2023 | 08-15-2022 | Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50. | Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process. | Ultra Chem Labs Corp / 5-10 gallons | Class II | Terminated |
| D-0017-2023 | 08-15-2022 | Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50. | Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process. | Ultra Chem Labs Corp / 5-10 gallons | Class II | Terminated |
| D-1345-2022 | 08-10-2022 | Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04 | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Nephron Sterile Compounding Center LLC / 294 bags | Class II | Terminated |
| D-1346-2022 | 08-10-2022 | PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05 | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Nephron Sterile Compounding Center LLC / 2030 bags | Class II | Terminated |
| D-1344-2022 | 08-10-2022 | PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33 | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Nephron Sterile Compounding Center LLC / 13,500 vials | Class II | Terminated |
| D-1347-2022 | 08-10-2022 | PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34 | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Nephron Sterile Compounding Center LLC / 33,870 vials | Class II | Terminated |
| D-1467-2022 | 08-10-2022 | Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A. | cGMP deviation: Product held outside of appropriate temperature storage conditions. | Family Dollar Stores, Llc. / 1680 packages | Class II | Ongoing |
| D-1466-2022 | 08-10-2022 | Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White, Net Wt. 3.0 OZ. (85 g) UPC 0 35000 97008 4. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A. | cGMP deviation: Product held outside of appropriate temperature storage conditions. | Family Dollar Stores, Llc. / 840 packages | Class II | Ongoing |
| D-1468-2022 | 08-10-2022 | Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A. | cGMP deviation: Product held outside of appropriate temperature storage conditions. | Family Dollar Stores, Llc. / 840 packages | Class II | Ongoing |
| D-1465-2022 | 08-10-2022 | Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A. | cGMP deviation: Product held outside of appropriate temperature storage conditions. | Family Dollar Stores, Llc. / 1120 packages | Class II | Ongoing |
| D-1470-2022 | 08-10-2022 | Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. New York, NY 10022 U.S.A. | cGMP deviation: Product held outside of appropriate temperature storage conditions. | Family Dollar Stores, Llc. / 840 packages | Class II | Ongoing |
| D-1469-2022 | 08-10-2022 | Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 45836 0. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A. | cGMP deviation: Product held outside of appropriate temperature storage conditions. | Family Dollar Stores, Llc. / 1400 packages | Class II | Ongoing |
| D-1354-2022 | 08-10-2022 | Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01 Package NDCs: 0487-6232-01 | cGMP Deviations: deviations leading to potential cross-contamination. | Nephron Sc Inc / 5040 vials | Class II | Terminated |
| D-1463-2022 | 08-08-2022 | Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b) 55 U.S. Gallon drums (208 Liters) UPC 0 07 61841 02504 0, Midlab 140 Private Brand Way, Athens, TN 37303 | CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride. | Midlab Incorporated / 892 gallons and one 55-gallon drum | Class II | Terminated |
| D-1464-2022 | 08-08-2022 | Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottles, Southern Products & Services, Inc. 2515 Jake Drive Ste B, Cumming, GA 30028 | CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride. | Midlab Incorporated / | Class II | Terminated |
| D-1471-2022 | 08-08-2022 | Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24 | Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide. | Akorn, Inc / 5,226 Cartons (60 vials/carton) | Class III | Ongoing |
| D-1352-2022 | 08-04-2022 | Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ | Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet. | Akron Pharma, Inc. / 301,382 bottles | Class III | Terminated |
| D-1353-2022 | 08-04-2022 | Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ | Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet. | Akron Pharma, Inc. / 30,325 bottles | Class III | Terminated |
| D-1472-2022 | 08-04-2022 | Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4. | Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate. | LNK International, Inc. / 257,064 cartons | Class III | Terminated |
| D-1348-2022 | 08-04-2022 | Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60 Package NDCs: 36000-306-60; 36000-372-40 | Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment. | Baxter Healthcare Corporation / 85,680 bags | Class II | Terminated |
| D-1335-2022 | 08-02-2022 | Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02 Package NDCs: 47426-301-06; 47426-301-04; 47426-301-02; 47426-302-06; 47426-302-04; 47426-302-02; 47426-303-05; 47426-303-03; 47426-303-01; 47426-304-05; 47426-304-03; 47426-304-01; 47426-501-04; 47426-501-02; 47426-502-04; 47426-502-02; 47426-503-03; 47426-503-01; 47426-504-03; 47426-504-01 | Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit | HERON THERAPEUTICS, INC. / 1790 kits | Class III | Terminated |
| D-1328-2022 | 08-02-2022 | Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35. Package NDCs: 69097-341-35 | Lack of Assurance of Sterility: Complaints received of defective container closure. | CIPLA / 7,992 bottles | Class II | Terminated |
| D-1361-2022 | 08-01-2022 | PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24 | Defective Container: Product has incomplete induction seals. | Akorn, Inc / 14,712 bottles | Class II | Ongoing |
| D-0212-2024 | 07-29-2022 | Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%, packaged in Net Wt 6 oz. aluminum spray can, Distributed by: Edgewell Personal Care Brands, LLC, Shelton, CT 06484, UPC 0 79656 04041 8 | Chemical contamination: presence of benzene | Edgewell Personal Care Brands, LLC / 139,680 aluminum spray cans | Class I | Terminated |
| D-1343-2022 | 07-28-2022 | Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06 Package NDCs: 68180-658-06; 68180-658-01; 68180-659-06; 68180-659-07; 68180-659-01 | CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity. | Lupin Pharmaceuticals Inc. / 7,872/30 count bottles | Class II | Terminated |
| D-1362-2022 | 07-27-2022 | Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10 Package NDCs: 65162-755-10; 65162-755-50; 65162-757-10; 65162-757-50 | Failed dissolution specifications. | Amneal Pharmaceuticals of New York, LLC / 4,309 bottles | Class II | Terminated |
| D-1349-2022 | 07-27-2022 | Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56 | Subpotent Drug | Amerisource Health Services LLC / 4,160 vials | Class III | Terminated |
| D-1514-2022 | 07-27-2022 | Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / a) 920 syringes; b) 3263 syringes | Class II | Terminated |
| D-1332-2022 | 07-25-2022 | fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02. | Lack of Assurance of Sterility | SterRx, LLC / 360 bags | Class II | Terminated |
| D-1331-2022 | 07-25-2022 | FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01. | Lack of Assurance of Sterility | SterRx, LLC / 720 bags | Class II | Terminated |
| D-0068-2023 | 07-25-2022 | Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Only, distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, NDC 62756-071-60 Package NDCs: 62756-071-60; 62756-071-64 | Discoloration | SUN PHARMACEUTICAL INDUSTRIES INC / 14, 064 (30 sachets in a carton) | Class II | Terminated |
| D-1333-2022 | 07-22-2022 | SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285 | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil. | Distributor RFR, LLC. / 2000 cartons | Class I | Terminated |
| D-1334-2022 | 07-22-2022 | Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56 Package NDCs: 68001-313-56 | Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification. | Teva Pharmaceuticals USA Inc / 4162 cartons | Class III | Terminated |
| D-1302-2022 | 07-21-2022 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA; NDC 52544-691-30. Package NDCs: 52544-691-30; 52544-691-19; 52544-691-10; 52544-692-30; 52544-692-19; 52544-692-10; 52544-693-30; 52544-693-19; 52544-693-10; 52544-694-30; 52544-694-19; 52544-694-10; 52544-695-30; 52544-695-19; 52544-695-10 | Failed Dissolution Specifications: below specification limits for dissolution. | Teva Pharmaceuticals USA Inc / 8022 bottles | Class II | Terminated |
| D-1303-2022 | 07-21-2022 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30. | Failed Dissolution Specifications: below specification limits for dissolution. | Teva Pharmaceuticals USA Inc / 5677 bottles | Class II | Terminated |
| D-1350-2022 | 07-21-2022 | SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9. | Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil. | Ultra Supplement LLC / 750 cartons | Class I | Terminated |
| D-1329-2022 | 07-20-2022 | Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4 Package NDCs: 42291-366-01; 42291-366-10; 42291-367-01; 42291-367-10; 42291-368-60; 42291-368-50; 42291-369-60; 42291-369-50 | Labeling: Label Error on Declared Strength | AVKARE Inc. / 8328 bottles | Class III | Terminated |
| D-1330-2022 | 07-19-2022 | Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06. Package NDCs: 64380-784-01; 64380-784-07; 64380-784-08; 64380-784-06; 64380-785-06; 64380-785-07; 64380-785-08; 64380-785-01; 64380-949-06; 64380-949-01 | Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets | Strides Pharma Inc. / 1032 bottles | Class II | Terminated |
| D-1475-2022 | 07-19-2022 | Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965765. | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Tsm Brands LLC / 350,000 bottles | Class II | Ongoing |
| D-1474-2022 | 07-19-2022 | Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734. | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Tsm Brands LLC / 2,700,000 bottles | Class II | Ongoing |
