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-0361-2021 | 03-29-2021 | Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.UPC 7 53727 26257 1 NDC: 64009-336-85 Package NDCs: 64009-336-85; 64009-336-90; 64009-336-91 | CGMP Deviations | Spartan Chemical Co Inc / 400 containers | Class II | Terminated |
| D-0363-2021 | 03-29-2021 | Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53525 26287 8 NDC: 64009-332-72 Package NDCs: 64009-332-75; 64009-332-78; 64009-332-72 | CGMP Deviations | Spartan Chemical Co Inc / 1,200 cases | Class II | Terminated |
| D-0362-2021 | 03-29-2021 | Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26116 1 NDC: 64009-333-95 Package NDCs: 64009-333-95; 64009-333-98 | CGMP Deviations | Spartan Chemical Co Inc / 2,152 containers | Class II | Terminated |
| D-0332-2021 | 03-26-2021 | Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only, Manufactured for: Lupin Pharmaceutical, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Mandideep 462 046, India. Package NDCs: 68180-401-03; 68180-401-01; 68180-401-02; 68180-402-01; 68180-402-03; 68180-402-02 | Superpotent Drug | Lupin Pharmaceuticals Inc. / a) 6,816 bottles; b) 3,960 bottles and c) 7,038 bottles | Class II | Terminated |
| D-0366-2021 | 03-26-2021 | Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3. | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil. | Antoto-K / 200 cartons | Class II | Terminated |
| D-0352-2021 | 03-25-2021 | Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. | S & B Story LLC / N/A | Class II | Ongoing |
| D-0351-2021 | 03-25-2021 | PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. | Namoo Enterprise LLC / N/A | Class II | Terminated |
| D-0327-2021 | 03-25-2021 | Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080 | CGMP Deviaitons | Cosette Pharmaceuticals, Inc. / a) 30 mL: 7724 b) 60 mL: 8064 bottles | Class II | Terminated |
| D-0325-2021 | 03-25-2021 | Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India, NDC 62756-142-02. Package NDCs: 62756-142-01; 62756-142-02; 62756-143-01 | Failed Moisture Limits: Out of specification for water content | SUN PHARMACEUTICAL INDUSTRIES INC / 2520 bottles | Class III | Terminated |
| D-0388-2021 | 03-24-2021 | Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules. | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil. | Bit & Bet LLC / 3894 ten-count boxes (38,940 capsules) | Class II | Terminated |
| D-0619-2021 | 03-22-2021 | TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Movo Mordisk Inc., Plainsboro, NJ 08536, NDC 0169-2660-90 (Pen), NDC 0169-2660-97 (Kit) Package NDCs: 0169-2660-15; 0169-2660-90; 0169-2660-97; 0169-2550-13; 0169-2550-90; 0169-2550-97; 0169-2662-11; 0169-2662-90 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0620-2021 | 03-22-2021 | TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2662-90 Package NDCs: 0169-2660-15; 0169-2660-90; 0169-2660-97; 0169-2550-13; 0169-2550-90; 0169-2550-97; 0169-2662-11; 0169-2662-90 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0621-2021 | 03-22-2021 | TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2550-90 (Pen), 0169-2550-97 (Kit) Package NDCs: 0169-2660-15; 0169-2660-90; 0169-2660-97; 0169-2550-13; 0169-2550-90; 0169-2550-97; 0169-2662-11; 0169-2662-90 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0617-2021 | 03-22-2021 | OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit) | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class II | Terminated |
| D-0615-2021 | 03-22-2021 | NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, Rx Only, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6339-90 (Pen), NDC 0169-6339-98 (Kit) Package NDCs: 0169-7501-11; 0169-7501-90; 0169-3303-12; 0169-3303-91; 0169-3303-90; 0169-6339-10; 0169-6339-90; 0169-6339-97; 0169-6339-98; 0169-6338-10; 0169-6338-90; 0169-6338-97; 0169-2001-90; 0169-2100-11; 0169-2101-12; 0169-2101-25 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0616-2021 | 03-22-2021 | NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90 Package NDCs: 0169-7501-11; 0169-7501-90; 0169-3303-12; 0169-3303-91; 0169-3303-90; 0169-6339-10; 0169-6339-90; 0169-6339-97; 0169-6339-98; 0169-6338-10; 0169-6338-90; 0169-6338-97; 0169-2001-90; 0169-2100-11; 0169-2101-12; 0169-2101-25 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0623-2021 | 03-22-2021 | Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2911-90 (Pen) NDC 0169-2911-97 (Kit) Package NDCs: 0169-2911-15; 0169-2911-90; 0169-2911-97 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0618-2021 | 03-22-2021 | Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2800-90 (Pen), NDC 0169-2800-97 (Kit) Package NDCs: 0169-2800-15; 0169-2800-90; 0169-2800-97 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class II | Terminated |
| D-0614-2021 | 03-22-2021 | Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6438-90 (Pen), NDC 0169-6438-98 (Kit) Package NDCs: 0169-3687-12; 0169-3687-92; 0169-6438-10; 0169-6438-90; 0169-6438-97; 0169-6438-98; 0169-6432-55; 0169-6432-10 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0613-2021 | 03-22-2021 | Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3201-90 Package NDCs: 0169-3201-11; 0169-3201-90; 0169-3204-15; 0169-3204-90; 0169-3204-97; 0169-3205-11; 0169-3205-15; 0169-3205-91; 0169-3205-95; 0169-3206-11; 0169-3206-15; 0169-3206-91; 0169-3206-95 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0611-2021 | 03-22-2021 | Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk, Inc., Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-3204-90 (Pen), NDC 0169-3204-97 (Kit) Package NDCs: 0169-3201-11; 0169-3201-90; 0169-3204-15; 0169-3204-90; 0169-3204-97; 0169-3205-11; 0169-3205-15; 0169-3205-91; 0169-3205-95; 0169-3206-11; 0169-3206-15; 0169-3206-91; 0169-3206-95 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0612-2021 | 03-22-2021 | Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3205-91 Package NDCs: 0169-3201-11; 0169-3201-90; 0169-3204-15; 0169-3204-90; 0169-3204-97; 0169-3205-11; 0169-3205-15; 0169-3205-91; 0169-3205-95; 0169-3206-11; 0169-3206-15; 0169-3206-91; 0169-3206-95 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class I | Terminated |
| D-0622-2021 | 03-22-2021 | ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagesvaerd, Denmark NDC 0169-4060-90 (Pen), 0169-4060-99 (Kit) Package NDCs: 0169-4060-13; 0169-4060-12; 0169-4060-90; 0169-4060-97; 0169-4060-98; 0169-4060-99 | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. | Novo Nordisk Inc / N/A | Class II | Terminated |
| D-0329-2021 | 03-22-2021 | Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10 Package NDCs: 33342-114-07; 33342-114-51; 33342-114-12; 33342-114-10; 33342-115-07; 33342-115-51; 33342-115-12; 33342-115-10; 33342-116-07; 33342-116-51; 33342-116-12; 33342-116-10; 33342-117-07; 33342-117-51; 33342-117-12; 33342-117-10 | Failed Impurities/Degradation Specifications | Macleods Pharma Usa Inc / 8015 packs | Class III | Terminated |
| D-0312-2021 | 03-19-2021 | Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10 | Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer | Golden State Medical Supply Inc. / N/A | Class II | Terminated |
| D-0349-2021 | 03-19-2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400 | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 40,720,900 cartons | Class II | Terminated |
| D-0343-2021 | 03-19-2021 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400 Package NDCs: 54365-400-32 | Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. | CareFusion 213, LLC / 952,100 cartons | Class I | Terminated |
| D-0344-2021 | 03-19-2021 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415 Package NDCs: 54365-400-33 | Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. | CareFusion 213, LLC / 1,434,000 cartons | Class I | Terminated |
| D-0345-2021 | 03-19-2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400 | Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. | CareFusion 213, LLC / 11,115,774 cartons | Class I | Terminated |
| D-0328-2021 | 03-19-2021 | Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5 | Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay | X-Gen Pharmaceuticals Inc. / 720 100-count (10x10 blister strips) | Class II | Terminated |
| D-0350-2021 | 03-19-2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415 | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 7,990,100 cartons | Class II | Terminated |
| D-0346-2021 | 03-19-2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415 | Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. | CareFusion 213, LLC / 6,869,400 cartons | Class I | Terminated |
| D-0330-2021 | 03-19-2021 | Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, DocRx, Mobile, AL 36608 | Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card. | Asclemed USA Inc. dba Enovachem Pharmaceuticals / N/A | Class III | Ongoing |
| D-0347-2021 | 03-19-2021 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400 Package NDCs: 54365-400-32 | Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 24,969,700 cartons | Class II | Terminated |
| D-0348-2021 | 03-19-2021 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415 Package NDCs: 54365-400-33 | Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 14,275,400 cartons | Class II | Terminated |
| D-0323-2021 | 03-18-2021 | LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411 | An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate. | Washington Homeopathic Products, Inc. / 300 liters | Class III | Terminated |
| D-0322-2021 | 03-18-2021 | Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411 | An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate. | Washington Homeopathic Products, Inc. / 114 bottles | Class III | Terminated |
| D-0321-2021 | 03-18-2021 | Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC 58770-190-42 | An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate. | Washington Homeopathic Products, Inc. / 1,909 bottles | Class III | Terminated |
| D-0326-2021 | 03-17-2021 | Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30 Package NDCs: 62332-087-30; 62332-087-91; 62332-088-30; 62332-088-91; 62332-089-30; 62332-089-91; 1905005661 | Labeling: Label-mixup | Alembic Pharmaceuticals Limited / 12288 bottles | Class I | Terminated |
| D-0591-2021 | 03-15-2021 | Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66 Package NDCs: 50474-470-66; 50474-470-09; 50474-470-14; 50474-370-66; 50474-570-66; 50474-570-09; 50474-570-14; 50474-670-66; 50474-770-66; 50474-770-09; 50474-770-14; 50474-870-15; 50474-970-63; 50474-970-75 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 101 bottles | Class II | Terminated |
| D-0490-2021 | 03-15-2021 | AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 Package NDCs: 23155-287-10; 23155-287-01; 23155-288-01; 23155-288-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 122 bottles | Class II | Terminated |
| D-0437-2021 | 03-15-2021 | IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS) Package NDCs: 59651-032-12; 59651-032-47 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 345 CARTONS | Class II | Terminated |
| D-0590-2021 | 03-15-2021 | VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35 Package NDCs: 0131-2477-35; 0131-2477-60; 0131-2477-99; 0131-2478-35; 0131-2478-60; 0131-2478-99; 0131-2479-35; 0131-2479-60; 0131-2479-99; 0131-2480-35; 0131-2480-60; 0131-2480-99; 0131-1810-67; 0131-5410-70; 0131-5410-71; 0131-5410-72 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 882 bottles | Class II | Terminated |
| D-0529-2021 | 03-15-2021 | Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10 Distributed by: Meda Pharmaceutical Inc. Somerset, New Jersey Package NDCs: 0037-6822-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 834 aerosol containers | Class II | Terminated |
| D-0583-2021 | 03-15-2021 | Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceuticals LTD. Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-202-30 Package NDCs: 13668-202-30; 13668-202-90; 13668-202-05; 13668-203-30; 13668-203-05; 13668-203-90 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 52 bottles | Class II | Terminated |
| D-0436-2021 | 03-15-2021 | xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Package NDCs: 0310-6270-30; 0310-6270-95; 0310-6280-30; 0310-6280-95; 0310-6250-30; 0310-6250-95; 0310-6260-30; 0310-6260-60; 0310-6260-94; 0310-6260-95; 0310-6225-60; 0310-6225-94 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 378 bottles | Class II | Terminated |
| D-0434-2021 | 03-15-2021 | Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation only 120 inhalations Rx Only NDC 0310-4600-12 Mfd for: AstraZeneca Pharmaceuticals, LP, Wilmington, DE 19850 Package NDCs: 0310-4600-12; 0310-4600-28; 0310-4600-39 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 355 inhalers | Class II | Terminated |
| D-0575-2021 | 03-15-2021 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-3241-01 RX; TABLETS Package NDCs: 0093-3241-01; 0093-3242-01; 0093-3243-56 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 235 bottles | Class II | Terminated |
| D-0476-2021 | 03-15-2021 | cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech Package NDCs: 50242-041-64; 50242-041-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1473 vials | Class II | Terminated |
| D-0458-2021 | 03-15-2021 | Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA Package NDCs: 0597-0280-36; 0597-0280-73; 0597-0280-90; 0597-0290-20; 0597-0290-59; 0597-0290-74; 0597-0295-61; 0597-0295-78; 0597-0295-88; 0597-0300-20; 0597-0300-45; 0597-0300-93 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 269 bottles | Class II | Terminated |
| D-0455-2021 | 03-15-2021 | Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597-0164-30 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA Package NDCs: 0597-0182-70; 0597-0182-07; 0597-0182-03; 0597-0182-30; 0597-0182-39; 0597-0182-90; 0597-0164-30; 0597-0164-39; 0597-0164-90; 0597-0164-70; 0597-0164-07 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 592 bottles | Class II | Terminated |
| D-0570-2021 | 03-15-2021 | Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30 Package NDCs: 17772-102-70; 17772-102-01; 17772-102-30; 17772-102-15; 17772-102-10; 17772-102-12; 17772-102-07; 17772-103-70; 17772-103-01; 17772-103-30; 17772-103-15; 17772-103-10; 17772-103-12; 17772-103-07; 17772-104-70; 17772-104-01; 17772-104-30; 17772-104-15; 17772-104-12; 17772-104-10; 17772-104-07; 17772-101-70; 17772-101-01; 17772-101-30; 17772-101-15; 17772-101-10; 17772-101-12; 17772-101-07 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 490 bottles | Class II | Terminated |
| D-0485-2021 | 03-15-2021 | Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Package NDCs: 68462-380-01; 68462-380-05; 68462-356-01; 68462-356-05 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 141 bottles | Class II | Terminated |
| D-0584-2021 | 03-15-2021 | Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-203-30 Package NDCs: 13668-202-30; 13668-202-90; 13668-202-05; 13668-203-30; 13668-203-05; 13668-203-90 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 37 bottles | Class II | Terminated |
| D-0568-2021 | 03-15-2021 | CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-692-01 Package NDCs: 63304-692-01; 63304-692-05; 63304-692-77; 63304-692-03; 63304-693-16; 63304-693-01; 63304-693-03; 63304-693-05; 63304-693-77; 63304-693-11; 63304-693-62 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 223 bottles | Class II | Terminated |
| D-0536-2021 | 03-15-2021 | Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark Package NDCs: 0169-1715-30; 0169-1715-90; 0169-1704-30; 0169-1709-30; 0169-4303-01; 0169-4303-13; 0169-4303-90; 0169-4303-93; 0169-4303-30; 0169-4303-99; 0169-4307-01; 0169-4307-13; 0169-4307-30; 0169-4314-01; 0169-4314-13; 0169-4314-30; 0169-4815-30; 0169-4815-90; 0169-4804-30; 0169-4809-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1189 cartons | Class II | Terminated |
| D-0518-2021 | 03-15-2021 | BENZOYL PEROXIDE WASH 5% 148ML; NDC/UPC 0536-1259-63; OTC; LIQUID Package NDCs: 0536-1259-19; 0536-1259-63 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 37 BOTTLE | Class II | Terminated |
| D-0449-2021 | 03-15-2021 | Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA Package NDCs: 59385-021-01; 59385-021-60; 59385-022-01; 59385-022-60; 59385-023-01; 59385-023-60; 59385-024-01; 59385-024-60; 59385-025-01; 59385-025-60; 59385-026-01; 59385-026-60; 59385-027-01; 59385-027-60 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 47 cartons | Class II | Terminated |
| D-0424-2021 | 03-15-2021 | ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 135 CARTON | Class II | Terminated |
| D-0554-2021 | 03-15-2021 | Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer Labs Division of Pfizer Inc., NY, NY 10017 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 940 cartons | Class II | Terminated |
| D-0550-2021 | 03-15-2021 | HYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo, Allegan, MI 49010, NDC: 0574-7093-12 Package NDCs: 0574-7090-12; 0574-7093-12 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 95 suppositories | Class II | Terminated |
| D-0483-2021 | 03-15-2021 | Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Manufactured by: Glenmark Generics Ltd Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430 Package NDCs: 68462-292-90; 68462-292-01; 68462-292-05; 68462-293-90; 68462-293-01; 68462-293-05; 68462-260-30; 68462-260-90; 68462-260-01; 68462-260-05; 68462-260-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 513 bottles | Class II | Terminated |
| D-0592-2021 | 03-15-2021 | Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00 Package NDCs: 0832-0111-00; 0832-0111-50; 0832-0111-89; 0832-0111-03 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 271 bottles | Class II | Terminated |
| D-0500-2021 | 03-15-2021 | Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan Tablets Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd Nagoya 462-0024 Japan Package NDCs: 66869-104-90; 66869-204-90; 66869-204-07; 66869-404-90; 66869-404-07 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 453 bottles | Class II | Terminated |
| D-0564-2021 | 03-15-2021 | Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Princeton, NJ 08540, NDC 0781-3451-70 Package NDCs: 0781-3450-70; 0781-3450-95; 0781-3451-70; 0781-3451-96; 0781-3451-95 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 8 vials | Class II | Terminated |
| D-0486-2021 | 03-15-2021 | Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufactured for: Viiv Healthcare Research Triangle Park, NC 27709 by GlaxoSmithKline Research Triangle Park, NC 27709 Package NDCs: 49702-231-13; 49702-258-37; 49702-272-59 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 2264 bottles | Class II | Terminated |
| D-0499-2021 | 03-15-2021 | Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01 Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc. 750 Lexington Avenue, 20th Floor New York, NY 10022 USA Package NDCs: 59922-631-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 136 bottles | Class II | Terminated |
| D-0512-2021 | 03-15-2021 | Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA Package NDCs: 0904-5306-60; 0904-5306-80; 0904-5306-61; 0904-5306-24; 0904-2056-61; 0904-2035-24 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 88 bottles | Class II | Terminated |
| D-0459-2021 | 03-15-2021 | Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA Package NDCs: 0597-0280-36; 0597-0280-73; 0597-0280-90; 0597-0290-20; 0597-0290-59; 0597-0290-74; 0597-0295-61; 0597-0295-78; 0597-0295-88; 0597-0300-20; 0597-0300-45; 0597-0300-93 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 751 bottles | Class II | Terminated |
| D-0484-2021 | 03-15-2021 | EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS Package NDCs: 68462-321-90; 68462-321-10; 68462-321-30; 68462-322-30; 68462-322-90; 68462-322-10; 68462-323-30; 68462-323-90; 68462-323-05; 68462-324-30; 68462-324-90; 68462-324-05 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 7 CARTON | Class II | Terminated |
| D-0576-2021 | 03-15-2021 | PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73 Package NDCs: 0093-1172-01; 0093-1172-10; 0093-1174-01; 0093-1174-10; 0093-4125-73; 0093-4125-74; 0093-4127-73; 0093-4127-74 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 91 bottles | Class II | Terminated |
| D-0474-2021 | 03-15-2021 | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUP Package NDCs: 71930-026-18; 71930-026-43 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 73 carton | Class II | Terminated |
| D-0402-2021 | 03-15-2021 | Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A. Package NDCs: 0032-1203-70; 0032-1203-64; 0032-1206-07; 0032-1206-01; 0032-1206-56; 0032-1212-07; 0032-1212-01; 0032-1212-46; 0032-1212-13; 0032-1224-07; 0032-1224-01; 0032-1224-46; 0032-3016-28; 0032-3016-13; 0032-3016-50; 0032-3016-12; 0032-0045-70; 0032-0045-30; 0032-0046-30; 0032-0046-70; 0032-0047-30; 0032-0047-70; 0032-2636-70; 0032-2636-01; 0032-2636-30; 0032-2637-70; 0032-2637-01; 0032-2637-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1669 bottles | Class II | Terminated |
| D-0543-2021 | 03-15-2021 | Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 31 bottles | Class II | Terminated |
| D-0482-2021 | 03-15-2021 | Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA Inhaler containing 30 doses (60 blisters total) Rx Only NDC 0173-0887-10 GlaxoSmithKline Research Triangle Park, NC 27709 Package NDCs: 0173-0887-10; 0173-0887-14; 0173-0887-61; 0173-0893-10; 0173-0893-14; 0173-0893-61 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 903 inhalers | Class II | Terminated |
| D-0524-2021 | 03-15-2021 | Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA Package NDCs: 0006-5363-03; 0006-5363-08; 0006-5363-09; 0006-5363-06; 0006-5363-07; 0006-5363-10; 0006-5364-03; 0006-5364-08; 0006-5364-09; 0006-5364-06; 0006-5364-07 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 215 bottles | Class II | Terminated |
| D-0538-2021 | 03-15-2021 | Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Zhejiang 317024 China For Par Pharmaceutical Companes, Inc. Spring Valley, NY 10977 U.S.A. Package NDCs: 49884-561-11; 49884-561-01; 49884-561-05; 49884-562-11; 49884-562-01; 49884-562-05; 49884-563-11; 49884-563-01; 49884-563-05; 49884-564-11; 49884-564-01; 49884-564-05; 49884-604-11; 49884-604-01; 49884-604-05; 49884-605-11; 49884-605-01; 49884-605-05 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 131 bottles | Class II | Terminated |
| D-0571-2021 | 03-15-2021 | Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 160 bottles | Class II | Terminated |
| D-0566-2021 | 03-15-2021 | Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limited, NDC 49281-752-21 Package NDCs: 49281-752-78; 49281-752-21; 49281-752-98; 49281-752-22 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 406 vials | Class II | Terminated |
| D-0417-2021 | 03-15-2021 | Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612 Package NDCs: 0456-1203-30; 0456-1203-04; 0456-1203-07; 0456-1201-30; 0456-1201-04; 0456-1201-07; 0456-1202-30; 0456-1202-04; 0456-1202-07 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1529 bottles | Class II | Terminated |
| D-0469-2021 | 03-15-2021 | PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES Package NDCs: 43598-291-90; 43598-291-05; 43598-291-79; 43598-291-66; 43598-291-78; 43598-292-90; 43598-292-05; 43598-292-79; 43598-292-66; 43598-292-78; 43598-293-90; 43598-293-05; 43598-293-79; 43598-293-66; 43598-293-78; 43598-294-90; 43598-294-05; 43598-294-79; 43598-294-66; 43598-294-78; 43598-295-90; 43598-295-05; 43598-295-79; 43598-295-66; 43598-295-78; 43598-296-90; 43598-296-05; 43598-296-79; 43598-296-66; 43598-296-78; 43598-297-90; 43598-297-05; 43598-297-79; 43598-297-66; 43598-297-78; 43598-298-90; 43598-298-05; 43598-298-79; 43598-298-66; 43598-298-78 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 6 CONTAINERS | Class II | Terminated |
| D-0433-2021 | 03-15-2021 | Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850 Package NDCs: 0186-0777-08; 0186-0777-60; 0186-0777-18; 0186-0777-39; 0186-0777-28; 0186-0776-60; 0186-0776-94 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1278 bottles | Class II | Terminated |
| D-0451-2021 | 03-15-2021 | NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL) Package NDCs: 72618-3000-2; 72618-3001-1; 72618-3001-2; 72618-3001-4 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1240 CARTON | Class II | Terminated |
| D-0412-2021 | 03-15-2021 | Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA Package NDCs: 62332-115-30; 62332-115-31; 62332-115-91; 62332-116-30; 62332-116-31; 62332-116-71; 62332-117-30; 62332-117-31; 62332-117-71; 2005005745 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 71 bottles | Class II | Terminated |
| D-0507-2021 | 03-15-2021 | NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Laboratories, Inc. Canton, MS 39046 Package NDCs: 68047-186-16 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 24 bottles | Class II | Terminated |
| D-0496-2021 | 03-15-2021 | Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement Rx NDC 64661-650-30 Manufactured for: JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584 Package NDCs: 64661-650-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 11 bottles | Class II | Terminated |
| D-0435-2021 | 03-15-2021 | xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791 Package NDCs: 0310-6270-30; 0310-6270-95; 0310-6280-30; 0310-6280-95; 0310-6250-30; 0310-6250-95; 0310-6260-30; 0310-6260-60; 0310-6260-94; 0310-6260-95; 0310-6225-60; 0310-6225-94 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 664 bottles | Class II | Terminated |
| D-0509-2021 | 03-15-2021 | Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India Package NDCs: 33342-190-07; 33342-190-10; 33342-190-12; 33342-190-44; 33342-191-07; 33342-191-10; 33342-191-12; 33342-191-44; 33342-192-07; 33342-192-10; 33342-192-12; 33342-192-44; 33342-193-07; 33342-193-10; 33342-193-12; 33342-193-44 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 33 bottles | Class II | Terminated |
| D-0581-2021 | 03-15-2021 | Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-30 Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Package NDCs: 0591-4060-30; 0591-3659-30; 0591-3660-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 57 bottles | Class II | Terminated |
| D-0481-2021 | 03-15-2021 | TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL Package NDCs: 0173-0887-10; 0173-0887-14; 0173-0887-61; 0173-0893-10; 0173-0893-14; 0173-0893-61 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 4065 CARTON | Class II | Terminated |
| D-0561-2021 | 03-15-2021 | Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation Aerosol 120 inhalations Rx only Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, NDC 0310-7372-20 Package NDCs: 0310-7370-20; 0310-7372-20 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 905 inhalers | Class II | Terminated |
| D-0457-2021 | 03-15-2021 | Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA Package NDCs: 0597-0270-12; 0597-0270-73; 0597-0270-94; 0597-0275-33; 0597-0275-81; 0597-0275-88 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 52 bottles | Class II | Terminated |
| D-0403-2021 | 03-15-2021 | Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each weekly blister pack contains 7 tablets of elagolix 150 mg AbbVie Inc. North Chicago, IL 60064 Package NDCs: 0074-0038-28; 0074-0038-01; 0074-0038-07; 0074-0039-56; 0074-0039-01; 0074-0039-14 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 210 cartons | Class II | Terminated |
| D-0551-2021 | 03-15-2021 | Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36 Package NDCs: 45802-054-35; 45802-054-05; 45802-054-36; 45802-055-35; 45802-055-36; 45802-055-05; 45802-049-35 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 178 tubes | Class II | Terminated |
| D-0470-2021 | 03-15-2021 | Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1 bottle | Class II | Terminated |
| D-0495-2021 | 03-15-2021 | TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES Package NDCs: 71858-0013-4; 71858-0013-1; 71858-0013-2; 71858-0012-4; 71858-0012-1; 71858-0012-2; 71858-0005-4; 71858-0005-1; 71858-0005-2; 71858-0010-4; 71858-0010-1; 71858-0010-2; 71858-0015-4; 71858-0015-1; 71858-0015-2; 71858-0020-4; 71858-0020-1; 71858-0020-2; 71858-0025-4; 71858-0025-1; 71858-0025-2; 71858-0030-4; 71858-0030-1; 71858-0030-2; 71858-0035-4; 71858-0035-1; 71858-0035-2; 71858-0040-4; 71858-0040-1; 71858-0040-2; 71858-0045-4; 71858-0045-1; 71858-0045-2; 71858-0050-4; 71858-0050-1; 71858-0050-2; 71858-0055-4; 71858-0055-1; 71858-0055-2; 71858-0060-4; 71858-0060-1; 71858-0060-2; 71858-0017-4; 71858-0017-1; 71858-0017-2 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 25 boxes | Class II | Terminated |
| D-0419-2021 | 03-15-2021 | Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc. Birmingham, AL 35242 Package NDCs: 58914-301-80; 58914-301-85 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 31 tubes | Class II | Terminated |
| D-0489-2021 | 03-15-2021 | bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 Package NDCs: 23155-191-10; 23155-191-01; 23155-192-10; 23155-192-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 32 bottles | Class II | Terminated |
| D-0556-2021 | 03-15-2021 | Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets) Rx only NDC 0069-0471-03 Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY 10017 Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-28; 0069-0471-03; 0069-0471-28 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1040 cartons | Class II | Terminated |
| D-0425-2021 | 03-15-2021 | TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS Package NDCs: 60505-0593-4; 60505-0593-1 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 325 CARTONS | Class II | Terminated |
