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 March 15, 2024 and include a total of 16056 recall reports.

Recall Number Recall Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-0327-202402-13-2024Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
Package NDCs: 69238-1273-6
Failed Impurities/Degradation Specifications: Out-of-specification test results.Amneal Pharmaceuticals of New York, LLC / 46,037 BottlesClass IIOngoing
D-0348-202402-12-2024Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01
Package NDCs: 42571-315-30; 42571-315-90; 42571-315-05; 42571-315-32; 42571-315-11; 42571-315-20; 42571-315-91; 42571-315-01; 42571-316-30; 42571-316-90; 42571-316-32; 42571-316-11; 42571-316-20; 42571-316-91; 42571-316-01
CGMP Deviations: Out of specification for residual solvents.Micro Labs Limited / 24,768 bottlesClass IIOngoing
D-0347-202402-12-2024CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.
Package NDCs: 0187-0006-10; 0187-0006-25; 0187-0006-35
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.MCKESSON CORPORATION / 42 unitsClass IIOngoing
D-0324-202402-09-2024HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
Package NDCs: 0904-6440-61; 0904-6441-61; 0904-6442-61; 0904-6443-10; 0904-6443-61
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 8,198 unitsClass IIOngoing
D-0326-202402-09-2024Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
Package NDCs: 60505-0829-1
Potential presence of Burkholderia cepacia complex (BCC)Apotex Corp. / 292,752 bottlesClass IIOngoing
D-0341-202402-06-2024Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01
Package NDCs: 43825-200-01
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.Mallinckrodt Hospital Products Inc. / 421 vials involved in this recall (2,448 vials distributed)Class IIOngoing
D-0344-202402-06-2024SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.Today The World / 11500 boxesClass IOngoing
D-0345-202402-06-2024Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.comMarketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.Today The World / 5500 boxesClass IOngoing
D-0340-202402-06-2024Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1
Package NDCs: 63004-8710-1; 63004-8710-2
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.Mallinckrodt Hospital Products Inc. / 8 vials involved in recall (16,479 vials distributed)Class IIOngoing
D-0343-202402-06-2024Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, NevadaMarketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.Today The World / 7000 boxesClass IOngoing
D-0337-202402-05-2024Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60.
Package NDCs: 43386-038-60
Labeling: Incorrect or Missing Package InsertLupin Pharmaceuticals Inc. / Class IIOngoing
D-0346-202402-01-2024TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3Chemical Contamination; presence of benzene.Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company / 59,644 cansClass IOngoing
D-0318-202402-01-2024Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.NATCO Pharma Limited / 4260 bottlesClass IIOngoing
D-0320-202402-01-2024HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
Package NDCs: 68084-447-11; 68084-447-01
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.Amerisource Health Services LLC / 2,850 cartonsClass IIIOngoing
D-0314-202401-25-2024Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11
Package NDCs: 60687-538-11; 60687-538-21
CGMP DeviationsAmerisource Health Services LLC / 1,932 cartonsClass IIOngoing
D-0322-202401-25-2024Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58
Package NDCs: 0555-9012-79; 0555-9012-58
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.Teva Pharmaceuticals USA, Inc / 19,824 cartonsClass IIIOngoing
D-0338-202401-25-2024Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562.CGMP DeviationsAlpha Aromatics / 676 gallonsClass IIOngoing
D-0321-202401-25-2024Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
Package NDCs: 0555-9009-80; 0555-9009-42; 0555-9010-79; 0555-9010-58; 0555-9008-79; 0555-9008-67
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.Teva Pharmaceuticals USA, Inc / 12,916 cartonsClass IIIOngoing
D-0336-202401-23-2024Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20
Package NDCs: 0338-0112-20; 0338-0108-20; 0338-0116-20
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.Baxter Healthcare Corporation / 13,000 bagsClass IIOngoing
D-0325-202401-22-2024Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.IntegraDose Compounding Services LLC / 1,299 syringesClass IIOngoing
D-0331-202401-19-2024Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115CGMP Deviations: Potential Glass and Silicone particulates in productBestco LLC / 46 cases/6 pack eachClass IIOngoing
D-0329-202401-19-2024Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115CGMP Deviations: Potential Glass and Silicone particulates in productBestco LLC / 16 cases/4 pack eachClass IIOngoing
D-0328-202401-19-2024CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115CGMP Deviations: Potential Glass and Silicone particulates in productBestco LLC / 78 cases/18 packs eachClass IIOngoing
D-0330-202401-19-2024Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115CGMP Deviations: Potential Glass and Silicone particulates in productBestco LLC / 21 cases/4 pack eachClass IIOngoing
D-0332-202401-19-2024Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115CGMP Deviations: Potential Glass and Silicone particulates in productBestco LLC / a) 1597 cases/ 12 pack each b) 73 cases/4 pack eachClass IIOngoing
D-0289-202401-19-2024Omeza Skin Protectant, Skin Protectant Gel 10*2mL VialsCGMP DeviationsOMEZA LLC / 1210 vialsClass IIOngoing
D-0288-202401-19-2024Omeza Lidocaine Lavage pain relief oil 10*2mL VIALSCGMP DeviationsOMEZA LLC / 4390 vialsClass IIOngoing
D-0312-202401-18-2024Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01
Package NDCs: 55111-320-30; 55111-320-01; 55111-320-05; 55111-320-79; 55111-320-78; 55111-321-30; 55111-321-01; 55111-321-05; 55111-321-79; 55111-321-78; 55111-322-30; 55111-322-01; 55111-322-05; 55111-322-79; 55111-322-78
Misprint on tabletDr. Reddy's Laboratories, Inc. / 59,336 bottlesClass IIIOngoing
D-0264-202401-18-2024Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 47335-721-83.
Package NDCs: 47335-721-83; 47335-721-81; 47335-721-13; 47335-722-83; 47335-722-88; 47335-722-18
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 55,272 bottlesClass IIOngoing
D-0266-202401-18-2024Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-639-83.
Package NDCs: 47335-578-83; 47335-578-81; 47335-578-13; 47335-684-83; 47335-684-81; 47335-684-13; 47335-639-83; 47335-639-81; 47335-639-13; 47335-685-83; 47335-685-81; 47335-685-13; 47335-579-83; 47335-579-81; 47335-579-13
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 11,400 bottlesClass IIOngoing
D-0271-202401-18-2024Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-307-88.
Package NDCs: 47335-307-88; 47335-307-13; 47335-308-88; 47335-308-13
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 1220 bottlesClass IIOngoing
D-0263-202401-18-2024Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.
Package NDCs: 47335-379-83; 47335-380-83; 47335-600-83
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 1,728 bottlesClass IIOngoing
D-0273-202401-18-2024Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.
Package NDCs: 51660-998-30; 51660-998-55; 51316-800-90; 51316-800-70; 51316-800-45; 51316-800-30; 51316-800-15; 51316-800-08
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 54,504 bottlesClass IIOngoing
D-0270-202401-18-2024Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81.
Package NDCs: 47335-539-83; 47335-539-81; 47335-539-88; 47335-539-08; 47335-539-18; 47335-614-83; 47335-614-81; 47335-614-88; 47335-614-18; 47335-613-83; 47335-613-81; 47335-613-88; 47335-613-08; 47335-613-18
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 15,768 bottlesClass IIOngoing
D-0265-202401-18-2024Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83.
Package NDCs: 47335-721-83; 47335-721-81; 47335-721-13; 47335-722-83; 47335-722-88; 47335-722-18
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 19,992 bottlesClass IIOngoing
D-0272-202401-18-2024Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88.
Package NDCs: 47335-307-88; 47335-307-13; 47335-308-88; 47335-308-13
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 14,568 bottlesClass IIOngoing
D-0267-202401-18-2024Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.
Package NDCs: 47335-578-83; 47335-578-81; 47335-578-13; 47335-684-83; 47335-684-81; 47335-684-13; 47335-639-83; 47335-639-81; 47335-639-13; 47335-685-83; 47335-685-81; 47335-685-13; 47335-579-83; 47335-579-81; 47335-579-13
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 9,408 bottlesClass IIOngoing
D-0313-202401-18-2024Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05
Package NDCs: 55111-320-30; 55111-320-01; 55111-320-05; 55111-320-79; 55111-320-78; 55111-321-30; 55111-321-01; 55111-321-05; 55111-321-79; 55111-321-78; 55111-322-30; 55111-322-01; 55111-322-05; 55111-322-79; 55111-322-78
Misprint on tabletDr. Reddy's Laboratories, Inc. / 14,425 bottlesClass IIIOngoing
D-0268-202401-18-2024Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.
Package NDCs: 63304-175-13
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 10,690 bottlesClass IIOngoing
D-0269-202401-18-2024Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-613-81.
Package NDCs: 47335-539-83; 47335-539-81; 47335-539-88; 47335-539-08; 47335-539-18; 47335-614-83; 47335-614-81; 47335-614-88; 47335-614-18; 47335-613-83; 47335-613-81; 47335-613-88; 47335-613-08; 47335-613-18
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 6552 bottlesClass IIOngoing
D-0342-202401-17-2024Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01
Package NDCs: 42023-159-01; 42023-159-25; 42023-168-01; 0404-9810-01
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.Henry Schein Inc. and Glove Club HSI Gloves Inc. / 1,099 Single Dose VialsClass IIOngoing
D-0339-202401-16-2024Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57
Package NDCs: 67877-749-57
Failed Impurities/Degradation Specification: Out of specification for organic impuritiesAscend Laboratories, LLC / 71,244 sachetsClass IIOngoing
D-0286-202401-16-2024OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.CGMP Deviations: products may not conform to the labeled specifications.Den-Mat Holdings, LLC / 344 tubesClass IIOngoing
D-0287-202401-16-2024Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436.CGMP Deviations: products may not conform to the labeled specifications.Den-Mat Holdings, LLC / 10,103 unitsClass IIOngoing
D-0319-202401-15-2024Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.Amneal Pharmaceuticals of New York, LLC / 858 bottlesClass IIOngoing
D-0335-202401-12-2024Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.Neptune Resources, LLC / 4,932 boxesClass IOngoing
D-0333-202401-12-2024Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.Neptune Resources, LLC / 1,000,000 bottlesClass IOngoing
D-0334-202401-12-2024Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.Neptune Resources, LLC / 117,000 bottlesClass IOngoing
D-0285-202401-11-2024Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11
Package NDCs: 60687-575-11; 60687-575-21; 60687-586-11; 60687-586-01
Failed Impurities/Degradation Specification.Amerisource Health Services LLC / 1,568 cartonsClass IIOngoing
D-0232-202401-11-2024Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10
Package NDCs: 42023-164-01; 42023-164-25; 42023-164-10; 42023-190-01; 42023-219-01; 42023-219-10; 42023-220-01; 42023-220-10; 42023-237-01; 42023-237-10; 42023-268-01; 42023-268-10
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.Par Sterile Products LLC / 1721 cartonsClass IIOngoing
D-0262-202401-10-2024Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01.
Package NDCs: 71839-104-01
Lack of Sterility Assurance: Aseptic process simulation failure.BE PHARMACEUTICALS AG / 22,176 VialsClass IIOngoing
D-0315-202401-10-2024Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44
Package NDCs: 53329-147-44
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.MEDLINE INDUSTRIES, LP - Northfield / 1,786 tubesClass IIOngoing
D-0275-202401-08-2024Budesonide Extended-Release Tablets 9mg, 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 0591-2510-30
Package NDCs: 0591-2510-30
Failed Dissolution SpecificationsTeva Pharmaceuticals USA, Inc / 10,672 30-count bottlesClass IIOngoing
D-0284-202401-05-2024Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
Package NDCs: 68180-658-06; 68180-658-01; 68180-659-06; 68180-659-01; 68180-659-07
Failed Impurities/Degradation SpecificationsLupin Pharmaceuticals Inc. / 165,60 bottlesClass IIOngoing
D-0283-202401-05-2024Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06
Package NDCs: 68180-658-06; 68180-658-01; 68180-659-06; 68180-659-01; 68180-659-07
Failed Impurities/Degradation SpecificationsLupin Pharmaceuticals Inc. / 15,576 BottlesClass IIOngoing
D-0259-202401-04-2024Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56
Package NDCs: 68462-185-56
Failed Excipient Specifications: OOS for assay of Isopropyl AlcoholGlenmark Pharmaceuticals Inc., USA / 38,496 bottlesClass IIOngoing
D-0323-202401-04-2024Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03
Package NDCs: 24338-850-03; 24338-851-03; 24338-852-03; 24338-853-03; 24338-854-03; 24338-855-03; 24338-856-03
Labeling: Label Mix-upAzurity Pharmaceuticals, Inc. / 4,662 bottlesClass IOngoing
D-0274-202401-03-2024Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Package NDCs: 68180-405-01; 68180-407-03; 68180-407-04; 68180-416-11; 68180-416-08; 68180-423-11; 68180-423-08
Failed Impurities/Degradation SpecificationsLupin Pharmaceuticals Inc. / 4,608 BottlesClass IIOngoing
D-0223-202401-02-2024Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15
Package NDCs: 55111-179-30; 55111-179-15; 55111-179-03; 55111-179-10; 55111-180-30; 55111-180-15; 55111-180-03; 55111-180-10
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.Dr. Reddy's Laboratories, Inc. / 38,952 bottlesClass IIOngoing
D-0222-202412-29-2023buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03
Package NDCs: 16571-862-03; 16571-862-09; 16571-862-50; 16571-862-10; 16571-863-03; 16571-863-09; 16571-863-50; 16571-863-10
Presence of Foreign Tablets/CapsulesRising Pharma Holding, Inc. / 47,976 bottlesClass IIOngoing
D-0260-202412-29-2023Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-752-16
Package NDCs: 64380-752-16
Failed Dissolution SpecificationsStrides Pharma Inc. / 396 50-count bottlesClass IIOngoing
D-0237-202412-29-2023Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90
Package NDCs: 67877-626-90; 67877-626-01; 67877-626-05; 67877-626-06
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.Ascend Laboratories, LLC / 3,288 bottlesClass IIOngoing
D-0215-202412-28-2023Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.Seaway Pharma Inc. / 4,176 bottlesClass IIOngoing
D-0214-202412-28-2023Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.
Package NDCs: 63868-607-01
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.Seaway Pharma Inc. / 7,992 bottlesClass IIOngoing
D-0216-202412-28-2023Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.
Package NDCs: 63868-605-01; 63868-676-01
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.Seaway Pharma Inc. / 7,992 bottlesClass IIOngoing
D-0217-202412-28-2023Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0
Package NDCs: 63868-608-01
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.Seaway Pharma Inc. / 8,160 bottlesClass IIOngoing
D-0282-202412-28-2023VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.Denver Solutions, LLC DBA Leiters Health / 7,548 IV bagsClass IOngoing
D-0279-202412-28-2023PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.Denver Solutions, LLC DBA Leiters Health / 29,016 IV bagsClass IOngoing
D-0280-202412-28-2023PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.Denver Solutions, LLC DBA Leiters Health / 12,564 IV bagsClass IOngoing
D-0277-202412-28-2023FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.Denver Solutions, LLC DBA Leiters Health / 8,976 IV bagsClass IOngoing
D-0278-202412-28-2023FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.Denver Solutions, LLC DBA Leiters Health / 13,920 IV bagsClass IOngoing
D-0281-202412-28-2023VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.Denver Solutions, LLC DBA Leiters Health / 10,152 IV bagsClass IOngoing
D-0218-202412-28-2023DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Package NDCs: 49230-206-20; 49230-206-30; 49230-206-32; 49230-206-50; 49230-206-60; 49230-206-62; 49230-206-52; 49230-209-23; 49230-209-30; 49230-209-32; 49230-209-50; 49230-209-60; 49230-209-62; 49230-209-52; 49230-212-23; 49230-212-30; 49230-212-32; 49230-212-50; 49230-212-60; 49230-212-62; 49230-212-52
Lack of Sterility AssuranceFresenius Medical Care Holdings, Inc. / 69,590 bagsClass IIOngoing
D-0317-202412-26-2023Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059Microbial Contamination of Non-Sterile ProductsHaleon US Holdings LLC / 21,900 bottlesClass IOngoing
D-0316-202412-26-2023Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059Microbial Contamination of Non-Sterile ProductsHaleon US Holdings LLC / a) 31,632 bottles; b) 336,528 bottlesClass IOngoing
D-0257-202412-26-2023Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11
Package NDCs: 68084-214-11; 68084-214-01
Superpotent drug: Assay results were slightly above specification at the time zero point.Amerisource Health Services LLC / 6,344 cartonsClass IIIOngoing
D-0230-202412-21-2023Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-311-10.
Package NDCs: 82645-311-10
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.Pharma Nobis LLC / 53,268 BottlesClass IIOngoing
D-0233-202412-21-20234.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).
Package NDCs: 0409-5534-24; 0409-5534-14
Presence of Particulate Matter; identified as glassPfizer Inc. / 34000 CartonsClass IOngoing
D-0229-202412-21-2023CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl. oz, 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 / 13,344 bottlesClass IIOngoing
D-0235-202412-21-2023Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carton), 0409-4911-34 (case).
Package NDCs: 0409-1630-15; 0409-1630-10; 0409-9630-15; 0409-9630-05; 0409-4910-11; 0409-4910-34; 0409-4911-11; 0409-4911-34
Presence of Particulate Matter; identified as glassPfizer Inc. / 24400 CartonsClass IOngoing
D-0234-202412-21-20238.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-6637-14 (case).
Package NDCs: 0409-4916-24; 0409-4916-14; 0409-6637-24; 0409-6637-14
Presence of Particulate Matter; identified as glassPfizer Inc. / 21200 CartonsClass IOngoing
D-0261-202412-21-2023Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18
Package NDCs: 61703-323-22; 61703-332-18
Presence of particulate matter: glassPFIZER / 3,546 vialsClass IOngoing
D-0231-202412-21-2023Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Cherry Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-312-10.
Package NDCs: 82645-312-10
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.Pharma Nobis LLC / 7,404 BottlesClass IIOngoing
D-0228-202412-21-2023Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distributed by: Walgreen Co, 200 Wilmot Rd, Deerfield, IL 60015, NDC 0363-0427-98.
Package NDCs: 0363-0427-98
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.Pharma Nobis LLC / 49,716 BottlesClass IIOngoing
D-0227-202412-21-2023Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxative, Oral Solution, Cherry Flavor 10 fl. oz, Distributed by AmerisourceBergen, 1 West First Ave, Conshochoken, PA 19428, NDC 46122-741-38
Package NDCs: 46122-741-38
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.Pharma Nobis LLC / 24,684 BottlesClass IIOngoing
D-0236-202412-21-2023Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made in India. NDC 63736-378-02, Can UPC 3 63736 37882 0; Case UPC 1 03 63736 37882 7
Package NDCs: 63736-378-02
Chemical Contamination: presence of benzeneInsight Pharmaceuticals LLC, a Prestige Consumer Healthcare company / 34,704 cansClass IOngoing
D-0221-202412-20-2023Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.
Package NDCs: 68180-153-01; 68180-153-03; 68180-153-06; 68180-153-02; 68180-153-11; 68180-153-12
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.Lupin Pharmaceuticals Inc. / 100=29,184 bottles; 500=2922 bottlesClass IIOngoing
D-0219-202412-15-2023Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
Package NDCs: 55111-525-30; 55111-525-01; 55111-525-05; 55111-525-79; 55111-525-78; 55111-526-30; 55111-526-01; 55111-526-05; 55111-526-79; 55111-526-78; 55111-527-30; 55111-527-01; 55111-527-05; 55111-527-79; 55111-527-78
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.Dr. Reddy's Laboratories, Inc. / 8,280 bottlesClass IIOngoing
D-0152-202412-13-2023Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC 42582-900-06.CGMP Deviations: Stability data does not support expiry date.Private Label Partners, Inc. / 3,396 bottlesClass IIOngoing
D-0160-202412-12-2023ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869-10
Package NDCs: 0173-0869-10; 0173-0869-06; 0173-0869-61
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of SpecificationGlaxoSmithKline LLC / 67,508 inhalersClass IIIOngoing
D-0205-202412-11-2023Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO 63045, NDC# 68645-523-54
Package NDCs: 68645-521-54; 68645-522-54; 68645-523-54
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.Legacy Pharmaceutical Packaging LLC / 161,664 bottlesClass IIOngoing
D-0155-202412-11-2023NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.Fagron, Inc / 46 containersClass IIOngoing
D-0157-202412-11-2023NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-1, Bar code 3 51552 00411 5Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.Fagron, Inc / 52 containersClass IIOngoing
D-0154-202412-11-2023NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.Fagron, Inc / 13 containersClass IIOngoing
D-0156-202412-11-2023NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552 00414 6Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.Fagron, Inc / 9 containersClass IIOngoing
D-0213-202412-08-2023Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Package NDCs: 52652-9001-1; 52652-9001-2; 52652-9001-3
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.Azurity Pharmaceuticals, Inc. / 2,220 bottlesClass IIIOngoing
D-0150-202412-04-2023Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. NDC 62756-589-88
Package NDCs: 62756-589-83; 62756-589-01; 62756-589-88; 62756-589-08; 62756-589-18; 62756-590-83; 62756-590-01; 62756-590-88; 62756-590-08; 62756-590-18; 62756-591-83; 62756-591-01; 62756-591-88; 62756-591-08; 62756-591-18
Failed Impurities/Degradation SpecificationsSUN PHARMACEUTICAL INDUSTRIES INC / 96,192 bottlesClass IIOngoing
D-0147-202411-29-2023ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.STAQ Pharma, Inc. / 2616 bagsClass IIOngoing
D-0206-202411-29-2023Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7. Amazon's ASIN# B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZMarketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.Meta Herbal / 500 blister packsClass IOngoing
D-0204-202411-22-2023Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las Vegas, NV, NDC 72682-8721-3.Presence of Particulate Matter.AnazaoHealth Corporation / 3,363 vialsClass IIOngoing