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 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 | Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point. | Akorn, Inc / 5,226 Cartons (60 vials/carton) | Class III | Ongoing |
| 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-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-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-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-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-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-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-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-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 |
| 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-1294-2022 | 07-18-2022 | Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90 Package NDCs: 59746-447-30; 59746-447-90; 59746-447-05; 59746-448-30; 59746-448-90; 59746-448-05; 59746-449-30; 59746-449-90; 59746-449-05 | Failed Dissolution Specifications | Jubilant Cadista Pharmaceuticals, Inc. / 28,560 bottles | Class II | Terminated |
| D-1293-2022 | 07-18-2022 | Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90 Package NDCs: 59746-447-30; 59746-447-90; 59746-447-05; 59746-448-30; 59746-448-90; 59746-448-05; 59746-449-30; 59746-449-90; 59746-449-05 | Failed dissolution specifications. | Jubilant Cadista Pharmaceuticals, Inc. / 9,600 bottles | Class II | Terminated |
| D-1506-2022 | 07-15-2022 | Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By Dolgencorp. LLC 100 Mission Ridge, Goodlettsville, TN 37072 or Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072; NDC 55910-183-38, UPC 0 72785 13418 8 Package NDCs: 55910-183-38 | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 42,912 bottles | Class I | Terminated |
| D-1511-2022 | 07-15-2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), a) CVS Health UPC 0 50428 33517 8 or UPC 0 50428 30594 2 Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; b) Best Choice UPC 0 70038 20049 9 Proudly Distributed By: Valu Merchandisers, Co. 5000 Kansas Ave Kansas City, KS 66106; c) Care One UPC 3 41520 31322 6 Distributed By: Foodhold U.S.A., LLC, Landover, MD 20785 or Distributed By: Adusa Distribution, LLC Salisbury, NC 28147; d) Cariba UPC 6 46702 05701 2 Distributed by: Cariba International P.O. Box 1208 Safety Harbor, Florida 34595; e) Cruz Blanca UPC 3 0869-7403-08 2 or 3 08697 40308 2 Fabricado por Vi-Jon Inc. Smyrna, TN 37167 U.S.A. Dist.; f) Discount Drug Mart UPC 0 93351 02820 5 Distributed By: Discount Drug Mart 211 Commerce Drive, Medina, Ohio 44256; g) Equaline NDC 41163-709-38 UPC 0 41163 50067 9 Distributed by SUPERVALU INC. Eden Prairie, MN 55344 USA or Distributed By UNFI Providence, RI 02908 USA; h) Equate NDC 49035-506-38 UPC 6 81131 28714 2 Distributed By: Walmart Inc., Bentonville, AR 72716; i) Exchange Select 6 14299 40420 5 Manufactured For Your Military Exchanges By: Vi-Jon Inc. 8515 Page Avenue, St. Louis, MO 63114; j) Family Wellness UPC 0 32251 58082 6 Distributed By: Midwood Brands, LLC 500 Volvo Parkway Chesapeake, VA 23330; k) Good Sense NDC 50804-166-38 UPC 8 46036 00737 4 Distributed By: Geiss, Destin & Dunn, Inc. Peachtree City, GA 30269 or Distributed by: Perrigo Direct, Inc. Peachtree City, GA 30269; l) Harris Teeter UPC 0 72036 72612 4 Proudly Distributed By: Harris Teeter, LLC Matthews, NC 28105; m) HEB UPC 0 41220 51086 3 Made With Pride & Care For H-E-B San Antonio, TX 78204; n) Health Mart NDC 62011-0380-1 UPC 0 52569 14215 8 Distributed by McKesson One Post Street, San Francisco, CA 94104; o) Kroger NDC 30142-899-38 UPC 0 41260 00182 6 Distributed By The Kroger CO Cincinnati, Ohio 45202; p) Leader Sugar-Free NDC 70000-0424-1 UPC 0 96295 13554 1 Distributed By Cardinal Health Dublin, OH 43017; q) Major NDC 0904-6787-44 UPC 3 09046 78744 0 Distributed By: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152; r) Meijer NDC 41250-708-38 UPC 7 13733 45945 7 Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544; s) Premier Value UPC 8 40986 03530 2 Distributed by: Pharmacy Value Alliance LLC. 407 East Lancaster Avenue, Wayne, PA 19087; t) Publix NDC 56062-266-38 UPC 0 41415 50673 2 Distributed By Publix Super Markets, Inc. 3300 Publix Corporate Parkway, Lakeland, FL 33811; u) Quality Choice UPC 6 35515 90125 4 Distributed by C.D.M.A., Inc. 43157 W 9 Mile Rd Novi, MI 48375; v) Rexall UPC 0 72785 13418 8 Distributed By Dolgencorp. LLC 100 Mission Ridge Goodlettsville, TN 37072 or Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072; w) Rite Aid NDC 11822-4330-2 UPC 0 11822 43300 6 Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 1701; x) Signature Care NDC 21130-709-38 UPC 3 21130 77915 5 Distributed By: Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566-0009; y) Sound Body UPC 0 72785 11479 1 Manufactured for Big Lots by: Vi-Jon, Inc. 8515 Page Avenue; St. Louis, MO 63114; z) Sunmark NDC 70677-0051-1 UPC 0 10939 90844 5 Distributed By McKesson One Post Street, San Francisco, CA 94104 or Distributed by McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141; aa) Swan NDC 0869-0166-38 UPC 0 72785 13405 8 Distributed by: Vi-Jon, Inc. One Swan Drive Smyrna, TN 37167; bb) Topcare health UPC 0 36800 45529 0 Distributed By Topco Associates, LLC. Elk Grove Village, IL 60007; cc) Up & Up NDC 11673-708-38 or NDC 11673-666-38 UPC 0 72785 12883 5 Dist. by Target Corp., Mpls., MN 55403; dd) Walgreens NDC 0363-8166-38 UPC 3 11917 20160 3 Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015 Package NDCs: 41163-709-38; 50804-166-38; 30142-899-38; 56062-266-38; 11822-4330-2; 21130-709-38; 11673-708-38; 0869-7403-08; 49035-506-38; 62011-0380-1; 70000-0424-1; 0904-6787-44; 41250-708-38; 70677-0051-1; 0869-0166-38; 11673-666-38; 0363-8166-38 | CGMP Deviations | Vi-Jon, LLC / 22,965,330 bottles | Class II | Terminated |
| D-1505-2022 | 07-15-2022 | P, magnesium citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By Publix Super Markets, Inc. 3300 Publix Corporate Parkway, Lakeland, FL 33811; NDC 56062-266-38 UPC 0 41415 50673 2 Package NDCs: 56062-266-38 | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 8,682 bottles | Class I | Terminated |
| D-1503-2022 | 07-15-2022 | Kroger, Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed By The Kroger CO Cincinnati, Ohio 45202; NDC 30142-899-38 UPC 0 41260 00182 6 Package NDCs: 30142-899-38 | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 44,976 bottles | Class I | Terminated |
| D-1508-2022 | 07-15-2022 | Topcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Cherry Flavor, 10 FL OZ (296 mL), Distributed By Topco Associates LLC Elk Grove Village, IL 60007; NDC 36800-164-38 UPC 0 36800 45530 6 Package NDCs: 36800-164-38 | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 18,588 bottles | Class I | Terminated |
| D-1502-2022 | 07-15-2022 | EQUALINE magnesium citrate saline laxative, oral solution, (1.745 g/fl oz), DYE FREE lemon flavor, 10 FL OZ (296 mL), Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA, or Distributed By UNFI Providence, RI 02908, NDC 41163-769-38 UPC 0 41163 50068 6 Package NDCs: 41163-769-38 | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 5,304 bottles | Class I | Terminated |
| D-1512-2022 | 07-15-2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 58790 3 Proudly Distributed By: Valu Merchandises, Co. 5000 Kansas Ave. Kansas City, KS 66106; b) Careone UPC 3 41520 00055 3 Distributed By: Foodhold U.S.A., LLC, Landover, MD 20785, Careone UPC 3 41520 00055 3 Distributed By: Adusa Distribution, LLC Salisbury, NC 28147; c) CVS Health UPC 0 50428 29733 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, CVS Health UPC 0 50428 28515 2 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; d) Equaline NDC 41163-769-38 UPC 0 41163 50068 6 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA, Equaline NDC: 41163-769-38 UPC 0 41163 50068 6 Distributed By UNFI Providence, RI 02908; Equate NDC 49035-593-38 UPC 6 81131 28716 6 Distributed By: Walmart Inc., Bentonville, AR 72716; Family Wellness NDC 56319-164-38 UPC 0 32251 57788 8; e) GoodSense NDC 50804-164-38 UPC 8 46036 00739 8 Distributed By: Geiss, Destin & Dunn, Inc. Peachtree City, GA 30269, GoodSense NDC 508-164-38 UPC 8 46036 00739 8 Distributed by: Geiss, Destin & Dunn, Inc. A Perrigo Company, Peachtree City, GA 30269; f) HEB UPC 0 41220 51087 0 Made with Pride & Care For H-E-B San Antonio, TX 78204; g) Health Mart NDC 62011-0381-1 UPC 0 52569 14216 5 Distributed by McKesson One Post Street, San Francisco, CA 94104, Health Mart NDC 62011-0381-1 NDC 0 52569 14216 5 Distributed by McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141; h) Leader Sugar-Free NDC 70000-0575-1 UPC 0 96295 14106 1 Distributed By Cardinal Health Dublin, Ohio 43017, Leader Sugar-Free NDC 70000-0576-1 UPC 0 96295 14105 4 Distributed By Cardinal Health Dublin, Ohio 43017; i) Meijer Sugar Free Low Sodium NDC 41250-769-38 UPC 7 13733 45944 0 Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544; j) Premier Value UPC 8 40986 03529 6 Distributed by: Pharmacy Value Alliance LLC 407 East Lancaster Avenue, Wayne, PA 19087; k) P NDC 56062-264-38 UPC 0 41415 50573 5 Distributed By Publix Super Markets, Inc. 3300 Publix Corporation Parkway, Lakeland, FL 33811; l) Quality Choice UPC 6 35515 90111 7 Distributed by C.D.M.A., Inc. 43157 W 9 Mile Rd Novi, MI 48375; Rexall UPC 0 72785 13416 4 Distributed By Dolgencorp, LLC 100 Mission Ridge Goodlettsville, TN 37072 USA, Rexall UPC 0 72785 13416 4 Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072; m) Rite Aid NDC 11822-4303-2 UPC 0 11822 43303 7 Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011; Signature Care NDC 21130-165-38 UPC 3 21130 78971 0 Distributed By Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566; n) Sunmark NDC 70677-0053-1 UPC 0 10939 91044 8 Distributed By McKesson One Post Street, San Francisco, CA 94104; o) Swan Very Low Sodium NDC 0869-0164-38 UPC 3 08690 69338 1 Distributed by: Vi-Jon, Inc. One Swan Drive Smyrna, TN 37167; p) TopCare Health NDC 36800-164-38 UPC 0 36800 45530 6 Distributed By Topco Associates LLC Elk Grove Village, IL 60007; q) Walgreens NDC 0363-8164-38 UPC 3 11917 20158 0 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 (red label), Walgreens NDC 0363-8164-38 UPC 3 11917 20158 0 Distributed By: Walgreen Co. 200 Wilmot RD., Deerfield, IL 60015 Package NDCs: 41163-769-38; 50804-164-38; 56062-264-38; 21130-165-38; 0869-0164-38; 36800-164-38; 49035-593-38; 56319-164-38; 62011-0381-1; 70000-0575-1; 70000-0576-1; 41250-769-38; 11822-4303-2; 70677-0053-1; 0363-8164-38 | CGMP Deviations | Vi-Jon, LLC / 10,070,526 | Class II | Terminated |
| D-1501-2022 | 07-15-2022 | equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), Grape Flavor, Distributed By: Walmart, Inc. Bentonville, AR 72716; NDC 49035-592-38 UPC 6 81131 28715 9 | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 18,324 bottles | Class I | Terminated |
| D-1507-2022 | 07-15-2022 | SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemony Flavor, 10 FL OZ (296 mL), Distributed by: Vi-Jon, Inc. One Swan Drive Smyrna, TN 37167; NDC 0869-0166-38 UPC 0 72785 13405 8 | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 27,612 bottles | Class I | Terminated |
| D-1513-2022 | 07-15-2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 66220 4 Proudly Distributed By: Valu Merchandisers, Co. 5000 Kansas Ave Kansas City, KS 66106; b) CVS Health UPC 0 50428 30745 8 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, CVS Health UPC 0 50428 32503 2 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; c) Equate NDC 49035-592-38 UPC 6 81131 28715 9 Distributed By: Walmart, Inc. Bentonville, AR 72716; d) HEB UPC 0 41220 51088 7 Made With Pride & Care For H-E-B San Antonio, TX 78204; Kroger UPC 0 41260 00871 9 Distributed By The Kroger Co. Cincinnati, Ohio 45202; e) Leader NDC 70000-0576-1 UPC 0 96295 14105 4 Distributed By Cardinal Health Dublin, Ohio 43017; f) Rexall UPC 0 72785 13417 1 Distributed By Dolgencorp, LLC 100 Mission Ridge Goodlettsville, TN 37072 USA, Rexall UPC 0 72785 13417 1 Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072; g) Walgreens NDC 0363-7162-38 UPC 3 11917 20159 7 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 (purple label), Walgreens NDC 0363-7162-38 UPC 3 11917 20159 7 Distributed By: Walgreen Co. 200 Wilmot RD., Deerfield, IL 60015 (blue label) | CGMP Deviations; | Vi-Jon, LLC / 8,064,834 | Class II | Terminated |
| D-1509-2022 | 07-15-2022 | Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8166-38 UPC 3 11917 20160 3 (green label) | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 29,172 bottles | Class I | Terminated |
| D-1504-2022 | 07-15-2022 | meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544; NDC 41250-708-38 UPC 7 13733 45945 7 | Microbial contamination of non-sterile products. | Vi-Jon, LLC / L 22,965,330 C 10,070,526 G 8,064,834 | Class I | Terminated |
| D-1351-2022 | 07-15-2022 | Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8. Package NDCs: 70710-1688-2; 70710-1688-8 | Failed Impurities/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc / 1116 boxes | Class II | Terminated |
| D-1510-2022 | 07-15-2022 | Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Grape Flavor, 10 FL OZ (296 mL), Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015; NDC 0363-7162-38 UPC 3 11917 20159 7 (purple label). | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 29,388 bottles | Class I | Terminated |
| D-1360-2022 | 07-15-2022 | Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734 | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. | Aire-Master of America Inc / 4 totes | Class II | Terminated |
| D-1356-2022 | 07-15-2022 | Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253 | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. | Aire-Master of America Inc / 9,176 cartons | Class II | Terminated |
| D-1359-2022 | 07-15-2022 | Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606 | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. | Aire-Master of America Inc / 5,064 bottles | Class II | Terminated |
| D-1357-2022 | 07-15-2022 | Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440 | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. | Aire-Master of America Inc / 4,632 cartons | Class II | Terminated |
| D-1355-2022 | 07-15-2022 | Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253 | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. | Aire-Master of America Inc / 18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drums | Class II | Terminated |
| D-1358-2022 | 07-15-2022 | Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606. | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. | Aire-Master of America Inc / 960 cartons | Class II | Terminated |
| D-1500-2022 | 07-15-2022 | CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), a) UPC 0 50428 30594 2; b) UPC 0 50428 33517 8; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. | Microbial contamination of non-sterile products. | Vi-Jon, LLC / 241,086 bottles | Class I | Terminated |
| D-1283-2022 | 07-14-2022 | Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna Industrial area, Verna - Goa, 403722, India; Mfd. for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, 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 / 8,136 bottles | Class II | Terminated |
| D-1288-2022 | 07-13-2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856179, NDC 43598-561-78 Package NDCs: 43598-560-79; 43598-560-78; 43598-561-79; 43598-561-78; 4359856179 | FAILED DISSOLUTION SPECIFICATIONS | Dr. Reddy's Laboratories, Inc. / 2,639 cartons | Class II | Terminated |
| D-1301-2022 | 07-13-2022 | Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per 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: particulate identified as a beetle. | Pfizer Inc. / 54,000 vials | Class I | Terminated |
| D-1287-2022 | 07-13-2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856079, NDC 43598-560-78 Package NDCs: 43598-560-79; 43598-560-78; 43598-561-79; 43598-561-78; 4359856079 | FAILED DISSOLUTION SPECIFICATIONS | Dr. Reddy's Laboratories, Inc. / 2,892 cartons | Class II | Terminated |
| D-1304-2022 | 07-11-2022 | Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India. Package NDCs: 68462-534-35; 68462-534-65; 68462-534-94; 68462-881-35; 68462-881-65; 68462-881-94 | Defective Container: Tube split from side seam | Glenmark Pharmaceuticals Inc., USA / 654,756 tubes | Class III | Ongoing |
| D-1300-2022 | 07-11-2022 | Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510-63), c) Net Wt. 60g tube (NDC 0115-1510-58), Rx only, Manufactured by: Tolmar, Inc., Fort Collins, CO, 80526, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 | Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time | Tolmar, Inc. / 1271 tubes | Class II | Terminated |
| D-1307-2022 | 07-11-2022 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01 Package NDCs: 0641-6044-01; 0641-6044-25; 0641-6046-01; 0641-6046-10; 0641-6045-01; 0641-6045-25; 0641-6047-01; 0641-6047-10 | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. | Hikma Pharmaceuticals USA Inc. / 4,739,000 vials | Class II | Terminated |
| D-1309-2022 | 07-11-2022 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01 Package NDCs: 0641-6048-01; 0641-6048-25; 0641-6050-01; 0641-6050-10; 0641-6049-01; 0641-6049-25; 0641-6051-01; 0641-6051-10 | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. | Hikma Pharmaceuticals USA Inc. / 713,550 vials | Class II | Terminated |
| D-1310-2022 | 07-11-2022 | Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01 Package NDCs: 0641-6044-01; 0641-6044-25; 0641-6046-01; 0641-6046-10; 0641-6045-01; 0641-6045-25; 0641-6047-01; 0641-6047-10 | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. | Hikma Pharmaceuticals USA Inc. / 82,700 vials | Class II | Terminated |
| D-1308-2022 | 07-11-2022 | Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01 Package NDCs: 0641-6003-01; 0641-6003-25; 0641-6002-01; 0641-6002-10; 0641-6001-01; 0641-6001-25; 0641-6000-01; 0641-6000-10 | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. | Hikma Pharmaceuticals USA Inc. / 301,400 vials | Class II | Terminated |
| D-1290-2022 | 07-08-2022 | Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g) a) Individual carton, UPC 0 37000 598534; b) 5-count Bundle, UPC 037000171867, Distributed. By Procter & Gamble, Cincinnati, OH 45202. | Labeling: Missing label: the product tube was missing a label and contained a different formulation. | The Procter & Gamble Company / 1,128 tubes | Class III | Completed |
| D-1285-2022 | 07-07-2022 | Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 | Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. | Apotex Corp. / 2010 bottles | Class II | Terminated |
| D-1292-2022 | 07-05-2022 | Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV | Labeling: Missing label: Label missing from some prefilled pens. | Mylan Pharmaceuticals Inc / 253,200 pens (50,650/5 per packs) | Class I | Terminated |
| D-1259-2022 | 06-30-2022 | Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 91,445 syringes | Class II | Terminated |
