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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0365-2022 | 12-02-2021 | Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. Package NDCs: 13668-268-30; 13668-268-01; 13668-268-10; 13668-268-31; 13668-268-05; 13668-271-01; 13668-271-10; 13668-271-49; 13668-271-05 | Failed Dissolution Specifications | Torrent Pharma Inc. / 15,336 Bottles | Class II | Terminated |
| D-0285-2022 | 12-01-2021 | Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30 | Superpotent; Hydrochlorothiazide | Torrent Pharma Inc. / 27,312 Bottles | Class III | Terminated |
| D-0265-2022 | 11-30-2021 | 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66 Package NDCs: 0409-7100-68; 0409-7100-66; 0409-7100-69; 0409-7100-67; 0409-7100-04; 0409-7100-02 | Lack of sterility assurance: bag has the potential to leak. | Pfizer Inc. / 765 bags | Class II | Terminated |
| D-0296-2022 | 11-30-2021 | Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64 Package NDCs: 63739-997-64 | Superpotent Drug: Minimally superpotent | Teligent Pharma, Inc. / 7,176 bottles | Class II | Ongoing |
| D-0295-2022 | 11-30-2021 | Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64 Package NDCs: 63739-997-64 | Superpotent Drug | Teligent Pharma, Inc. / 6,816 bottles | Class I | Ongoing |
| D-0298-2022 | 11-30-2021 | Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416 | Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol | Aroma Release Technologies Inc / 37 55-gallon drums | Class I | Terminated |
| D-0278-2022 | 11-29-2021 | Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01 | Defective container: Out of specification for container integrity leading to bottles leaking. | Preferred Pharmaceuticals, Inc. / 72 bottles | Class II | Ongoing |
| D-0327-2022 | 11-29-2021 | PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L | CGMP Deviations: failed stability results, inadequate laboratory investigations, | ULTRAtab Laboratories, Inc. / 14 bulk lots (approximately 1,987,951 tablets each) | Class II | Terminated |
| D-0288-2022 | 11-29-2021 | Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42 | Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL | Denver Solutions, LLC DBA Leiters Health / 1440 vials | Class II | Terminated |
| D-0246-2024 | 11-23-2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-380-10, UPC 0 37000 79884 2 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0240-2024 | 11-23-2021 | Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical spray can, Net WT 3.8 oz (107 g) cans, Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-387-10, UPC 0 37000 72974 7 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0256-2024 | 11-23-2021 | Secret Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-380-10, UPC 0 37000 79884 2 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0245-2024 | 11-23-2021 | Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Light Essentials, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-382-10, UPC 0 37000 72992 1 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0244-2024 | 11-23-2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Lavender, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-383-10, UPC: 0 37000 72986 0 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0247-2024 | 11-23-2021 | Secret, OUTLAST, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Completely Clean, Topical spray can 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-384-10, UPC 0 37000 74764 2 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0239-2024 | 11-23-2021 | Old Spice, SWEAT DEFENSE, STRONGER SWAGGER, Dry Spray, 48 Hour, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical Spray Can, Net WT 3.8 oz (107 g), Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC 69423-386-10, UPC 0 37000 73034 7 OR UPC 0 12044 04475 9 (12 Pack, older label) | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0250-2024 | 11-23-2021 | Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray, Topical spray can, Net WT 6.0 OZ (170g), Distributed by Procter & Gamble, Cincinnati, OH 45202. NDC: 37000-199-60, UPC 0 12044 00191 2 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0251-2024 | 11-23-2021 | Old Spice, SWEAT DEFENSE PURE SPORT PLUS, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical spray can, Net WT 3.8 oz (107 g) cans, Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-387-10, UPC 0 37000 72974 7 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0252-2024 | 11-23-2021 | Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Anti-Perspirant, Topical spray can 3.8 OZ (107 g), Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-385-10, UPC 0 37000 74947 9 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0248-2024 | 11-23-2021 | Secret OUTLAST Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Protecting Powder, Topical spray can 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-478-10, UPC 0 37000 74772 7 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0254-2024 | 11-23-2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5% Antiperspirant, Waterlily, Topical Spray Can, Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-381-10; UPC 0 37000 72372 1; 12/pack UPC 0 37000 72991 4 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0255-2024 | 11-23-2021 | Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Lavender, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-383-10, UPC: 0 37000 72986 0 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0249-2024 | 11-23-2021 | Old Spice Pure Sport 2021 Gift Set, Contains: Old Spice Pure Sport Body Wash 18 Fl Oz (532 mL), 2-in-1 Shampoo & Conditioner 13.5 Fl Oz (400 mL), and Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical spray can, Net WT 3.8 oz (107 g). Dist. by: Procter & Gamble, Cincinnati, OH 45202. Gift Set NDC 69423-590-01, UPC 12044 04853 5 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0241-2024 | 11-23-2021 | Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Anti-Perspirant, Topical spray can 3.8 OZ (107 g), Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-385-10, UPC 0 37000 74947 9 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0243-2024 | 11-23-2021 | Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Waterlily, Topical Spray Can, Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-381-10; UPC 0 37000 72372 1; 12/pack UPC 0 37000 72991 4 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0238-2024 | 11-23-2021 | Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray, Topical spray can, Net WT 6.0 OZ (170g), Distributed by Procter & Gamble, Cincinnati, OH 45202. NDC: 37000-199-60, UPC 0 12044 00191 2 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0242-2024 | 11-23-2021 | Secret, powder fresh, Aluminum chlorohydrate 24%, Anti-Perspirant/Deodorant, Topical spray can Net Wt., (a) 4OZ (113g), NDC 37000-134-11, UPC 0 37000 71109 4, (b) 6OZ (170g), NDC 37000-134-17, UPC 0 37000 71108 7; (c) twin pack-2 each can Net Wt. 6OZ (170g), NDC: 37000-134-01, UPC 0 37000 58690 6; Distr. by: Procter & Gamble, Cincinnati, OH 45202 Package NDCs: 37000-134-11; 37000-134-17; 37000-134-01 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0253-2024 | 11-23-2021 | Secret, powder fresh, (Aluminum chlorohydrate 24%), Anti-Perspirant/Deodorant, Topical spray can Net Wt., (a) 4OZ (113g), NDC 37000-134-11, UPC 0 37000 71109 4, (b) 6OZ (170g), NDC 37000-134-17, UPC 0 37000 71108 7; (c) twin pack-2 Topical spray cans, each can Net Wt. 6OZ (170g), NDC: 37000-134-01, UPC 0 37000 58690 6; Dist. by: Procter & Gamble, Cincinnati, OH 45202, Package NDCs: 37000-134-11; 37000-134-17; 37000-134-01 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0264-2022 | 11-19-2021 | Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated, Manufactured by: Lupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13. | Subpotent Drug | Lupin Pharmaceuticals Inc. / 4113 cartons | Class III | Terminated |
| D-0276-2022 | 11-19-2021 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01. Package NDCs: 31722-996-01; 31722-996-05; 31722-997-01; 31722-997-05 | Product Mix-up | Ascent Pharmaceuticals, Inc. / 9744 bottles | Class II | Terminated |
| D-0266-2022 | 11-19-2021 | AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2 | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles. | American Screening LLC / 153,336 bottles | Class I | Completed |
| D-0159-2024 | 11-17-2021 | Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex P.O. Box 5392, Oak Brook, IL 60522-5392. Package NDCs: 10157-4645-1; 10157-4645-2 | Chemical contamination: Presence of benzene | Blistex Inc / 243,386 cases (7 6-pack cases; 36 12-pack cases; 2,678,430 cans total) | Class I | Terminated |
| D-0262-2022 | 11-17-2021 | Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-690-50 | Lack of Assurance of Sterility | ASP CARES / 3077 vials | Class II | Terminated |
| D-0261-2022 | 11-17-2021 | Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30 | Lack of Assurance of Sterility | ASP CARES / 896 vials | Class II | Terminated |
| D-0286-2022 | 11-17-2021 | Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64 | Temperature Abuse; temperature excursion during shipping | Sandoz Inc / 45,036 cartons | Class I | Completed |
| D-0260-2022 | 11-17-2021 | Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-565-30 | Lack of Assurance of Sterility | ASP CARES / 1605 vials | Class II | Terminated |
| D-0263-2022 | 11-15-2021 | Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05 Package NDCs: 65862-142-01; 65862-142-05; 65862-142-99; 65862-143-01; 65862-143-05; 65862-143-99; 65862-144-01; 65862-144-05; 65862-144-99; 65862-145-01; 65862-145-05; 65862-145-99 | Failed Impurities/Degradation Specifications | Aurobindo Pharma USA Inc. / 7296 containers | Class III | Terminated |
| D-0269-2022 | 11-12-2021 | Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14. Package NDCs: 43598-823-14; 43598-823-31; 43598-823-35 | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 5016 cartons | Class III | Terminated |
| D-0267-2022 | 11-12-2021 | Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-7388-5. Package NDCs: 11822-7388-5 | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 4896 cartons | Class III | Terminated |
| D-0271-2022 | 11-12-2021 | Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07. | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 2184 cartons | Class III | Terminated |
| D-0275-2022 | 11-12-2021 | Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31. Package NDCs: 43598-823-14; 43598-823-31; 43598-823-35 | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 2,928 cartons | Class III | Terminated |
| D-0274-2022 | 11-12-2021 | Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30. | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 9,984 cartons | Class III | Terminated |
| D-0272-2022 | 11-12-2021 | 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1. | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 2496 cartons | Class III | Terminated |
| D-0270-2022 | 11-12-2021 | Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34. | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 2352 cartons | Class III | Terminated |
| D-0273-2022 | 11-12-2021 | Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30 | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / N/A | Class III | Terminated |
| D-0268-2022 | 11-12-2021 | Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20 | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 14976 cartons | Class III | Terminated |
| D-0321-2022 | 11-12-2021 | NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01. | Lack of Assurance of Sterility | SterRx, LLC / 74,508 bags | Class II | Terminated |
| D-0317-2022 | 11-12-2021 | Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02. | Lack of Assurance of Sterility | SterRx, LLC / 5000 bags | Class II | Terminated |
| D-0323-2022 | 11-12-2021 | PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01. | Lack of Assurance of Sterility | SterRx, LLC / 20640 bags | Class II | Terminated |
| D-0318-2022 | 11-12-2021 | MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01. | Lack of Assurance of Sterility | SterRx, LLC / 880 bags | Class II | Terminated |
| D-0305-2022 | 11-12-2021 | PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01. | Lack of Assurance of Sterility | SterRx, LLC / 18,948 bags | Class II | Terminated |
| D-0308-2022 | 11-12-2021 | EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01. | Lack of Assurance of Sterility | SterRx, LLC / 26,928 bags | Class II | Terminated |
| D-0301-2022 | 11-12-2021 | Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02. | Lack of Assurance of Sterility | SterRx, LLC / 880 units | Class II | Terminated |
| D-0314-2022 | 11-12-2021 | NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-476-01. | Lack of Assurance of Sterility | SterRx, LLC / 1428 bags | Class II | Terminated |
| D-0303-2022 | 11-12-2021 | NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01. | Lack of Assurance of Sterility | SterRx, LLC / 9360 bags | Class II | Terminated |
| D-0313-2022 | 11-12-2021 | Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01. | Lack of Assurance of Sterility | SterRx, LLC / 40 bags | Class II | Terminated |
| D-0311-2022 | 11-12-2021 | EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01. | Lack of Assurance of Sterility | SterRx, LLC / 684 bags | Class II | Terminated |
| D-0310-2022 | 11-12-2021 | EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01. | Lack of Assurance of Sterility | SterRx, LLC / 5832 bags | Class II | Terminated |
| D-0322-2022 | 11-12-2021 | NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01. | Lack of Assurance of Sterility | SterRx, LLC / 36,576 bags | Class II | Terminated |
| D-0315-2022 | 11-12-2021 | dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01. | Lack of Assurance of Sterility | SterRx, LLC / 8946 bags | Class II | Terminated |
| D-0324-2022 | 11-12-2021 | PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01. | Lack of Assurance of Sterility | SterRx, LLC / 23,136 bags | Class II | Terminated |
| D-0325-2022 | 11-12-2021 | Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03 | Lack of Assurance of Sterility | SterRx, LLC / 2886 bags | Class II | Terminated |
| D-0312-2022 | 11-12-2021 | Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02. | Lack of Assurance of Sterility | SterRx, LLC / 36360 bags | Class II | Terminated |
| D-0300-2022 | 11-12-2021 | Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01. | Lack of Assurance of Sterility | SterRx, LLC / 15660 bags | Class II | Terminated |
| D-0304-2022 | 11-12-2021 | EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-027-01. | Lack of Assurance of Sterility | SterRx, LLC / 2779 bags | Class II | Terminated |
| D-0302-2022 | 11-12-2021 | dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01. | Lack of Assurance of Sterility | SterRx, LLC / 24300 bags | Class II | Terminated |
| D-0320-2022 | 11-12-2021 | NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01. | Lack of Assurance of Sterility | SterRx, LLC / 121,584 bags | Class II | Terminated |
| D-0316-2022 | 11-12-2021 | Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01. | Lack of Assurance of Sterility | SterRx, LLC / 10660 bags | Class II | Terminated |
| D-0309-2022 | 11-12-2021 | EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01. | Lack of Assurance of Sterility | SterRx, LLC / 7548 bags | Class II | Terminated |
| D-0306-2022 | 11-12-2021 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01. | Lack of Assurance of Sterility | SterRx, LLC / 127,260 bags | Class II | Terminated |
| D-0319-2022 | 11-12-2021 | NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01. | Lack of Assurance of Sterility | SterRx, LLC / 1044 bags | Class II | Terminated |
| D-0307-2022 | 11-12-2021 | Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-826-01. | Lack of Assurance of Sterility | SterRx, LLC / 3540 bags | Class II | Terminated |
| D-0087-2024 | 11-09-2021 | Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05 Package NDCs: 42023-179-05 | Crystallization; identified as Buprenorphine free base | PAR Sterile Products LLC / | Class II | Terminated |
| D-0282-2022 | 11-08-2021 | Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-68 | Superpotent Drug | TOLMAR, Inc. / | Class II | Terminated |
| D-0287-2022 | 11-08-2021 | Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093. | Defective Container: Customer complaints for leaking bottles and dispensing issues. | Medline Industries Inc / 470,555 bottles | Class II | Terminated |
| D-0233-2022 | 11-04-2021 | Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86 | Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. | Amneal Pharmaceuticals of New York, LLC / 7,766 bottles | Class II | Terminated |
| D-0234-2022 | 11-04-2021 | Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86 | Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. | Amneal Pharmaceuticals of New York, LLC / 15,88 bottles | Class II | Terminated |
| D-0229-2022 | 11-03-2021 | Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50 Package NDCs: 67877-584-50; 67877-584-01; 67877-584-05; 67877-584-33 | Failed Impurities/Degradation Specifications | Ascend Laboratories LLC / 4104 bottles | Class II | Terminated |
| D-0094-2022 | 11-01-2021 | Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080. Package NDCs: 68094-231-59; 68094-231-62; 68094-231-61; 68094-231-01; 68094-231-58; 68094-330-59; 68094-330-62; 68094-330-61; 68094-030-59; 68094-030-62 | cGMP Deviations: Product manufactured with contaminated raw ingredient. | Precision Dose Inc. / 166,920 unit dose cups | Class II | Terminated |
| D-0095-2022 | 11-01-2021 | Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080. Package NDCs: 68094-231-59; 68094-231-62; 68094-231-61; 68094-231-01; 68094-231-58; 68094-330-59; 68094-330-62; 68094-330-61; 68094-030-59; 68094-030-62 | cGMP Deviations: Product manufactured with contaminated raw ingredient. | Precision Dose Inc. / 151,100 unit dose cups | Class II | Terminated |
| D-0235-2022 | 10-28-2021 | Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04 Package NDCs: 0591-3508-54; 0591-3508-04; 0591-3509-54; 0591-3509-04; 0591-3510-54; 0591-3510-04 | Failed Impurities/Degradation Specifications | Teva Pharmaceuticals USA / 64,978 patches | Class III | Terminated |
| D-0277-2022 | 10-28-2021 | VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-254-25 | Crystallization: Product appears to be turbid. | Apollo Care / 225 bags | Class II | Terminated |
| D-0232-2022 | 10-27-2021 | Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; (b) Manufactured By: Actavis Laboratories FL. Inc, Fort Lauderdale FL. 33314 USA, Distributed by Avista Pharma Inc. Parsippany, NJ 07054 USA. NDC 62037-597-90 Package NDCs: 62037-597-90; 62037-597-05; 62037-598-90; 62037-598-05; 62037-599-90; 62037-599-05; 62037-600-90; 62037-600-05 | Labelling: Incorrect Exp. Date | Teva Pharmaceuticals USA / 32316 bottles | Class II | Terminated |
| D-0618-2022 | 10-26-2021 | Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed By MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152. NDC 0904-6761-30 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 41,472 bottles | Class II | Terminated |
| D-0584-2022 | 10-26-2021 | Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-133-16 Package NDCs: 11673-133-16; 11673-133-26 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 22,140 bottles | Class II | Terminated |
| D-0599-2022 | 10-26-2021 | Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 FL OZ (118 mL) bottles per pack, Distributed by Walmart Inc., Bentonville, AR 72716. NDC: 49035-313-26 Package NDCs: 49035-313-26; 49035-313-34 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 83760 packs | Class II | Terminated |
| D-0580-2022 | 10-26-2021 | Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-313-26 Package NDCs: 49035-313-26; 49035-313-34 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 117552 bottles | Class II | Terminated |
| D-0608-2022 | 10-26-2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6378-1 Package NDCs: 11822-6378-1 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 9,888 bottles | Class II | Terminated |
| D-0629-2022 | 10-26-2021 | Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10 Package NDCs: 41250-989-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 144 bottles | Class II | Terminated |
| D-0627-2022 | 10-26-2021 | Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-696-10 Package NDCs: 55910-696-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 79,776 botles | Class II | Terminated |
| D-0589-2022 | 10-26-2021 | Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC: 49035-959-26 Package NDCs: 49035-959-26; 49035-959-08 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 30,144 bottles | Class II | Terminated |
| D-0626-2022 | 10-26-2021 | No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC 49035-388-10 Package NDCs: 49035-388-10; 49035-388-00; 49035-388-20 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 178,128 bottles | Class II | Terminated |
| D-0593-2022 | 10-26-2021 | Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204. NDC: 37808-759-26 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 3,840 bottles | Class II | Terminated |
| D-0583-2022 | 10-26-2021 | Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0971-26 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 14,064 bottles | Class II | Terminated |
| D-0611-2022 | 10-26-2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Dist. by Target Corp., Mpls., MN 55403. NDC 11673-935-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 89,208 bottles | Class II | Terminated |
| D-0586-2022 | 10-26-2021 | Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202. NDC: 30142-818-26 Package NDCs: 30142-818-26 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 3,120 bottles | Class II | Terminated |
| D-0598-2022 | 10-26-2021 | Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-946-16 Package NDCs: 49035-946-10; 49035-946-16 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 68,688 bottles | Class II | Terminated |
| D-0603-2022 | 10-26-2021 | Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC 410 TERRY AVENUE N.SEATTLE, WA 98109. NDC: 72288-703-10 Package NDCs: 72288-703-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 37,104 bottles | Class II | Terminated |
| D-0782-2022 | 10-26-2021 | artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5 | Chemical Contamination: presence of benzene, acetaldehyde, and acetal. | VIRGIN SCENT INC / 47,832 bottles | Class I | Terminated |
| D-0623-2022 | 10-26-2021 | No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10 Package NDCs: 41163-703-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 1,560 bottles | Class II | Terminated |
