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-0899-2021 | 09-22-2021 | Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213 | Lack of Assurance of Sterility | New Vitalis Pharmacy LLC dba New Vitalis Pharmacy / 1,347 vials | Class II | Terminated |
| D-0007-2022 | 09-22-2021 | Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1 | Lack of Assurance of Sterility | SSM Health Care St. Louis DBA SSM St. Clare Health Center / 385 bags | Class II | Terminated |
| D-0023-2022 | 09-22-2021 | AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06 | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA / 1,978 inhalers | Class II | Terminated |
| D-0025-2022 | 09-22-2021 | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06 | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA / 5,500 inhalers | Class II | Terminated |
| D-0024-2022 | 09-22-2021 | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06. | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA / 4,850 inhalers | Class II | Terminated |
| D-0022-2022 | 09-22-2021 | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08. | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA / 3,240 inhalers | Class II | Terminated |
| D-0021-2022 | 09-22-2021 | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08 | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Teva Pharmaceuticals USA / 10,665 inhalers | Class II | Terminated |
| D-0898-2021 | 09-21-2021 | Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14 | Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing. | SigmaPharm Laboratories LLC / 1192 bottles | Class II | Terminated |
| D-0018-2022 | 09-21-2021 | Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3 | CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues. | Sanitor Corporation / unknown | Class II | Terminated |
| D-0020-2022 | 09-17-2021 | GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11) | Failed Dissolution Specifications: results were above specification. | American Health Packaging / 2,266 cartons | Class II | Terminated |
| D-0896-2021 | 09-17-2021 | ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1 | Lack of sterility assurance. | IntegraDose Compounding Services LLC / 2,614 syringes | Class II | Terminated |
| D-0897-2021 | 09-17-2021 | ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1 | Lack of sterility assurance. | IntegraDose Compounding Services LLC / 589 bags | Class II | Terminated |
| D-0856-2021 | 09-17-2021 | Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper Package NDCs: 63323-452-00; 63323-452-01; 63323-454-00; 63323-454-01; 63323-455-00; 63323-455-01; 63323-458-00; 63323-458-01; 63323-451-00; 63323-451-01 | Defective container: Cracked vials leading to lack of sterility assurance | Fresenius Kabi USA LLC / 963000 vials | Class II | Terminated |
| D-0854-2021 | 09-15-2021 | Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42 | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. | American Health Packaging / 548 ccases | Class II | Terminated |
| D-0829-2021 | 09-14-2021 | Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30 | CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory. | Direct Rx / 2 bottles | Class II | Terminated |
| D-0798-2021 | 09-13-2021 | Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93 Package NDCs: 0378-3224-93; 0378-3224-77; 0378-3225-93; 0378-3225-77; 0378-3231-93; 0378-3231-77; 0378-3232-93; 0378-3232-77 | Failed Impurities/Degradation Specifications; out of specification for Related Compound | Viatris / 21,094 | Class III | Terminated |
| D-0019-2022 | 09-10-2021 | Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41 | Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT" | Piramal Critical Care, Inc. / 100 glass vials | Class II | Terminated |
| D-0799-2021 | 09-09-2021 | Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist. By The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-810-45, UPC 0 11110 37049 Package NDCs: 30142-810-72; 30142-810-43; 30142-810-45; 30142-810-14 | Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces | Vi-Jon, Inc. / 21,156 bottles | Class II | Terminated |
| D-0008-2022 | 09-09-2021 | Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01. | Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts. | Jacobus Pharmaceutical Company Inc. / 2,324 bottles | Class I | Terminated |
| D-0812-2021 | 09-09-2021 | Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99 Package NDCs: 65862-062-01; 65862-062-99; 65862-063-60; 65862-063-01; 65862-063-99; 65862-064-60; 65862-064-01; 65862-064-99 | Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet. | Aurobindo Pharma USA Inc. / 2,820 bottles | Class II | Terminated |
| D-0717-2022 | 09-08-2021 | TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30 Package NDCs: 58790-010-30 | Lack of Assurance of Sterility | Akorn, Inc. / 62,331 box | Class II | Terminated |
| D-0801-2021 | 09-03-2021 | Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21 | Failed Impurities/Degradation Specifications | Meitheal Pharmaceuticals Inc / 1,160 ten-pack cartons | Class III | Terminated |
| D-0805-2021 | 09-03-2021 | AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17 | Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples. | ICU Medical Inc / 2,112 Flexible Containers | Class I | Terminated |
| D-0814-2021 | 09-03-2021 | Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16 | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. | Morton Grove Pharmaceuticals, Inc. / 116,400 bottles | Class II | Completed |
| D-0816-2021 | 09-03-2021 | Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16 | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. | Morton Grove Pharmaceuticals, Inc. / 38,748 bottles | Class II | Completed |
| D-0815-2021 | 09-03-2021 | Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16 | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. | Morton Grove Pharmaceuticals, Inc. / 14,904 bottles | Class II | Completed |
| D-0005-2022 | 09-02-2021 | Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01 | Labeling: Incorrect Instructions | RISING PHARMACEUTICALS / 1,344 bottles | Class II | Ongoing |
| D-0853-2021 | 09-02-2021 | CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total NDC 69842-499-08 UPC 0 50428 64130 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 | Subpotent Drug | New Vision Pharmaceuticals LLC / 18,864 FG cartons | Class III | Terminated |
| D-0852-2021 | 09-02-2021 | Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 | Subpotent Drug | New Vision Pharmaceuticals LLC / 14,976 FG cartons | Class III | Terminated |
| D-0817-2021 | 09-01-2021 | Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747 | Subpotency: one product for active ingredient assay and another one for preservative assay | Monarch PCM, LLC / a) 3305 bottles; b) 840 bottles | Class III | Terminated |
| D-0818-2021 | 09-01-2021 | Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217, NDC 69367-174-01 UPC 3 69367 17401 5 Package NDCs: 69367-174-01 | Subpotency: one product for active ingredient assay and another one for preservative assay | Monarch PCM, LLC / 6305 tubes | Class III | Terminated |
| D-0823-2021 | 08-27-2021 | Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / 1800 bottles | Class II | Terminated |
| D-0824-2021 | 08-27-2021 | Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / 4752 bottles | Class II | Terminated |
| D-0827-2021 | 08-27-2021 | Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35 | Lack of Assurance of Sterility | Glenmark Pharmaceuticals Inc., USA / a) 5362 inhalers; b) 5593 inhalers | Class II | Terminated |
| D-0830-2021 | 08-27-2021 | Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711 | Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC). | DuPont Nutrition USA, Inc / 80 kg | Class I | Terminated |
| D-0821-2021 | 08-27-2021 | Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Package NDCs: 68462-188-01; 68462-188-05; 68462-189-01; 68462-189-05; 68462-190-30; 68462-190-50; 68462-190-01; 68462-190-05; 68462-178-01; 68462-178-05; 68462-179-01; 68462-179-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / 9552 bottles | Class II | Terminated |
| D-0820-2021 | 08-27-2021 | Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32 Package NDCs: 68462-317-40; 68462-317-32 | Lack of Assurance of Sterility | Glenmark Pharmaceuticals Inc., USA / 28658 cartons | Class II | Terminated |
| D-0822-2021 | 08-27-2021 | Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05 Package NDCs: 68462-188-01; 68462-188-05; 68462-189-01; 68462-189-05; 68462-190-30; 68462-190-50; 68462-190-01; 68462-190-05; 68462-178-01; 68462-178-05; 68462-179-01; 68462-179-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / a) 31248 bottles; b) 300 bottles | Class II | Terminated |
| D-0826-2021 | 08-27-2021 | Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05 Package NDCs: 68462-128-01; 68462-128-05; 68462-129-01; 68462-129-05; 68462-130-01; 68462-130-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / a) 216,454 bottles; b) 2166 bottles | Class II | Terminated |
| D-0825-2021 | 08-27-2021 | Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Package NDCs: 68462-128-01; 68462-128-05; 68462-129-01; 68462-129-05; 68462-130-01; 68462-130-05 | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA / 15936 bottles | Class II | Terminated |
| D-0828-2021 | 08-26-2021 | Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution Avrio Health LP Stamford, CT 06901-3431 NDC 67618-153-01, NDC 67618-153-03 Package NDCs: 67618-153-01; 67618-153-03 | Subpotent Drug | AVRIO HEALTH L.P / 75,828 shippers | Class II | Terminated |
| D-0003-2022 | 08-24-2021 | Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05. Package NDCs: 65628-204-05; 65628-205-10; 65628-206-05; 65628-208-10 | Product Mix-up: Incorrect diluent component included in the kit. | Azurity Pharmaceuticals, Inc. / 2,751 kits | Class I | Terminated |
| D-0291-2022 | 08-24-2021 | Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06 Package NDCs: 58593-275-06; 58593-275-10; 58593-275-04; 58593-275-08 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / 27,206 bottles | Class II | Terminated |
| D-0290-2022 | 08-24-2021 | Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-06 Package NDCs: 58593-235-06; 58593-235-04; 58593-235-08; 58593-235-29; 58593-235-10 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / 10,833 bottles | Class II | Terminated |
| D-0293-2022 | 08-24-2021 | Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08 Package NDCs: 58593-828-08 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / 4,026 bottles | Class II | Terminated |
| D-0292-2022 | 08-24-2021 | Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166 Package NDCs: 58593-829-06; 58593-829-04 | Microbial Contamination of Non-Sterile Products | Efficient Laboratories, Inc. / a) 7,800 bottles; b) 16,417 bottles | Class II | Terminated |
| D-0297-2022 | 08-23-2021 | Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29 | Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing | Teligent Pharma, Inc. / 3,792 bottles | Class II | Terminated |
| D-0851-2021 | 08-23-2021 | Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01 | Failed Dissolution Specifications | Viatris / 9,515 bottles | Class II | Terminated |
| D-0887-2021 | 08-20-2021 | ZTE 1013 Formula Antimicrobial - F&M , Contents 1000 ml, REMEDY: Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberus Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%, WHP Homeopathic Medicine, For Manufacturing Use Only; Manufactured for Optimal Health Dimensions, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 25411, | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 1 1/liter | Class II | Terminated |
| D-0873-2021 | 08-20-2021 | Althaea 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 1 OZ, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 10 bottles | Class II | Terminated |
| D-0890-2021 | 08-20-2021 | Strophanthus hisp 30X, Hives*, Sucrose/Lactose Pills , Packaged in (a) 2 dr, UPC 7 40640 47533 1; (b) 4 dr UPC 7 40640 47537 9; (c) 1 oz, UPC 7 40640 47541 6; (d) 2 oz, UPC 7 40640 47545 4; WHP Homeopathic Mecicine, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 91 bottles | Class II | Terminated |
| D-0860-2021 | 08-20-2021 | Yeast Guard Blend, Calcarea Carbonica 6X, Collinsonia Canadensis 3X, Kali Muriaicum 3X, WHP Homeopathic Medicine, For Manufacturing Use Only. 1.957 kg Lactose, Manufactured by Wasington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 1.957 kg. | Class II | Terminated |
| D-0877-2021 | 08-20-2021 | Quebracho 4C, Fever*, 20% Alcohol, Packaged as 100ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / N/A | Class II | Terminated |
| D-0878-2021 | 08-20-2021 | Viola od 6X, 30X, Bee Stings*, Sucrose/Lactose Pills, 6X Packaged in a) 4 Dram, UPC 7 40640 50139 9; 30X Packaged in b) 4 dr, UPC 7 40640 50141 2; c) 2 oz, UPC 7 40640 50149 8; WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / N/A | Class II | Terminated |
| D-0874-2021 | 08-20-2021 | Althaea 6X, Iritable Bladder* 20% Alcohol, Drops, packaged as 15 ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 10 bottles | Class II | Terminated |
| D-0880-2021 | 08-20-2021 | Z-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Only, REMEDY: Amygdalus Persica 10X, Arnica Montana 10X, Bellis Perennis 10X, Chromium Sulphuricum 10X, Citrus Vulgaris 10X, Derris Pinnata 13X, Franciscea Uniflora 13X, Hamamelis Virginiana 10X, Manganum Metallicum 10X, Ruta Graveolens 10X, Sarsaparilla 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensi. RX Only, Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2 1/liter bottle | Class II | Terminated |
| D-0864-2021 | 08-20-2021 | Cinnamomum 6X, Flatulence* Sucrose/Lactose Pills, Packaged as a) 4 Dram, b) 1 oz, and Cinnamomum 30X, Flatulence* Sucrose/Lactose Pills, Packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 6 bottles | Class II | Terminated |
| D-0891-2021 | 08-20-2021 | Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 6X, 26X, 30X, packaged in 15mL containers, Aconitum Napellus Fear* 20% Alcohol HPUS: 6X, 10X, packaged in 30mL containers Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 10X, 12X, 30X, packaged in 50mL containers Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, packaged in 100mL containers WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 562 bottles | Class II | Terminated |
| D-0862-2021 | 08-20-2021 | Cedar Fever Drops, 20% USP ALCOHOL, 30 mL, homeopathic drug for symptoms of cder allerges, Manufactured for Peoples RX, 3801 S Lamar, Austin, TX 78704. UPC 7 40640 64166 8 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 1,931 bottles | Class II | Terminated |
| D-0889-2021 | 08-20-2021 | Strophanthus hisp 30X, Hives*, 20% Alcohol, Packaged in (a) 15 mL, UPC 7 40640 47553 9; (b) 30mL UPC 7 40640 47557 7; (c) 100mL, UPC 7 40640 47565 2; WHP Homeopathic Mecicine, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 91 bottles | Class II | Terminated |
| D-0869-2021 | 08-20-2021 | Viola Odorata 4X, 10X, 12X, Bee Stings*, Sucrose/Lactose Pills, 4X Packaged in a) 2 Dram; 10X Packaged in b) 2 Dram; 12X Packaged in c) 2 Dram; d) 4 Dram; WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 12 bottles | Class II | Terminated |
| D-0784-2021 | 08-20-2021 | Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90 | Subpotent | Jubilant Cadista Pharmaceuticals, Inc. / 14,544 bottles | Class III | Terminated |
| D-0884-2021 | 08-20-2021 | Z-1070 Formula Anxioheal. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY:Causticum 30X, Conium Maculatum 8X, Conium Maculatum 12X, Crataegus Oxyacantha 12X, Crataegus Oxyacantha 30X, Ignatia Amara 24X, Lycopus Virginicus 12X, Phosphoricum Acidum 12X, Phosphoricum Acidum 24X, Rhus Toxicodendron 24X, Secale Cornutum 24X, Secale Cornutum 30X, Sepia 6X, Sepia 24X, Solanum Nigrum 30X, Zincum Valericanicum 8X, Zincum Valerianicum 12X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only. anufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2/1 Liter bottle | Class II | Terminated |
| D-0883-2021 | 08-20-2021 | Z-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Cholesterinum 10X, Avena Sativa 12X, Cynara Scolymos 12X, Phosphorus 12X, Oroticum Acidum 13X, Aesculus Hipposcastanum 24X, Carduus Marianus 24X, Chelidonium Majus 24X, Cimicifuga Racemosa 24X, Cinchona Officinalis 24X, Colocynthis 24X, Histaminum Hydrochloricum 24X, Lycopodium Clavatum 24X, Sulphur 24X, Tataxacum Officinale 24X, Veratrum Album 24X, Sepia 30X, Strontium Carbonicum 30X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only. anufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 3/1 Liter bottles | Class II | Terminated |
| D-0863-2021 | 08-20-2021 | Althaea Officinalis 4X, Iritable Bladder* packaged as Sucrose/Lactose Pills, 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 10 bottles | Class II | Terminated |
| D-0857-2021 | 08-20-2021 | Aconitum nap Fear* 87% Alcohol HPUS: 5X, 7X, 18X, 30X, packaged in 30 mL containers, Aconitum nap Fear* 87% Alcohol HPUS: 24X, packaged in 50 mL containers, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 562 bottles | Class II | Terminated |
| D-0886-2021 | 08-20-2021 | ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album 10X, Baptista Tinctoria 10X, Phosphorus 10X, Arnica Montana 10X, Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberis Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Alfalfa 3X, Dilution Alcohol 20%, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 225411, Manufactured for Optimal Health Dimensions, Washington Homeopathic Products, Inc. 260 JR Hawvernale Way, Berkeley Springs, WV, 25411, | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2 1/liter | Class II | Terminated |
| D-0885-2021 | 08-20-2021 | ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Arsenicum Album 10X, Baptisia Tinctoria 10X, Pulsatilla 10X, Lachesis Mutus 11X, Rhus Toxicodendron 10X, Belladonna 7X, Colchicum Autumnale 5X, Aconitum Napellus 8X, Astragalus Menziesli 8X, Carbo Vegetabilis 8X, Chamomilla 3X, Hydrastis Canadensis 3X, Echinacea Angustifolia 12X, Pulsatilla 11X, Anas Barariae, Hepatis ET 60C, Anas Barariae, Hepatis ET 100C, Anas Barariae, Hepatis ET 200C, Carduus Marianus 6X, Taraxacum Officinale 4X, Berberis Aquifolium 8X, Zingiber Officinal 8X, Allium Sativum 4X, Dilution Alcohol 20%. Causticum 30X, Conium Maculatum 8X, Conium Maculatum 12X, Crataegus Oxyacantha 12X, Crataegus Oxyacantha 30X, Ignatia Amara 24X, Lycopus Virginicus 12X, Phosphoricum Acidum 12X, Phosphoricum Acidum 24X, Rhus Toxicodendron 24X, Secale Cornutum 24X, Secale Cornutum 30X, Sepia 6X, Sepia 24X, Solanum Nigrum 30X, Zincum Valericanicum 8X, Zincum Valerianicum 12X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only. anufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2/1 Liter bottles | Class II | Terminated |
| D-0875-2021 | 08-20-2021 | Althaea 30X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 10 bottles | Class II | Terminated |
| D-0879-2021 | 08-20-2021 | Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine. For Manufacturing Use Only, REMEDY: Agrimonia Eupatoria 24X, Alfalfa 24X, Althaea Officinalis 24X, Avena Sativa 24X, Boldo 24X, Carduus Marianus 24X, Chioanathus Virginica 24X, Cynara Scolymus 24X, Iria Versicolor 24X, Millefolium 24X, Rumex Crispus 24X, Selenium Metallicum 12X, Selenium Metallicum 60X, Solidago Virgaurea 12X, Solidago Virgaurea 24X, Solidago Virgaurea 60X, Spiraea Ulmaira 24X, Taraxacum Officinale 24X, Urtica Dioica 24X, Uva-Ursi 24X, Zincum Muriaticum 13X, Zincum Mruiaticum 30X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensi. RX Only, Manufactured by Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2/1 Liter bottles | Class II | Terminated |
| D-0893-2021 | 08-20-2021 | Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X, 9X, 12X,30X, packaged in 1 oz containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 10X, 15X, 24X, 30X, packaged in 2 dr containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 30X, packaged in 2 oz containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 7X, 8X, 10X, 12X, 15X, 16X, 18X, 30X, packaged in 4 dram containers, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 562 bottles | Class II | Terminated |
| D-0868-2021 | 08-20-2021 | Verbena Officinalis 6X, Nervousness* Sucrose/Lactose Pills, Packaged 2 Dram, WHP Homeopathic Medicine, Washington Hoemopathis Producs, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 3 bottles | Class II | Terminated |
| D-0866-2021 | 08-20-2021 | Humulus 6X, 15X, Sucrose/Lactose Pills, 6X Packaged as a) 4dr, UPC 7 40640 33969 5; 15X Packaged as b) 4 dr; WHP Homeopathic Medicine. Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2 bottles | Class II | Terminated |
| D-0867-2021 | 08-20-2021 | Quebracho 4C, 5C, 6C, 12C, 30C, Fever*, Sucrose/Lactose Pills, 5C Packaged as a) 4dr; 6C Packaged as b) 4 Dram UPC 7 40640 44092 6; c) 2 oz UPC 7 40640 44100 8; 12C Packaged as d) 4 Dram; e) 2 oz; 30C Packaged as f) 2 dr UPC 7 40640 44090 2; g) 4 Dram, UPC 7 40640 44094 0; h) 1 oz, UPC 7 40640 44098 8; i) 2 oz, UPC 7 40640 44102 2; WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 61 bottles | Class II | Terminated |
| D-0876-2021 | 08-20-2021 | Cistus Canadensis 5X Coldness* 20% Alcohol drops, Packaged in a) 15ml; b) 50 ml; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / N/A | Class II | Terminated |
| D-0881-2021 | 08-20-2021 | ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Crataegus Oxyacantha 10X, Baryta Carbonica 10X, Digitalis Purpurea 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only, Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 1 1/Liter bottle | Class II | Terminated |
| D-0892-2021 | 08-20-2021 | Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 5X, 6X,15X, packaged in 1 oz containers, Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 7X, 12X, packaged in 2 dr containers, Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 12X, 20X, packaged in 2 oz containers, Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 5X, 9X,11X, 24X, packaged in 4 dr containers, Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 6X, 30X, packaged in 4 oz containers, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 562 bottles | Class II | Terminated |
| D-0858-2021 | 08-20-2021 | ZTE-105 Formula Gentle Detoxing. Contents 1000 mL, RX Only, REMEDY: Bryoni Alba 10X, Chelidonium Majus 10X, Carduus Marianus 10X, Dolichos Pruriens 10X, Solidago Vigaurea 10X, Alfalfa 10X, Boldo 10X, Cynara Scolymus 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%. WHP Homeopathic Medicine. For Manufacturing Use Only, Manufactured for Optimal Health Dimensi. Manufactured By: Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 3/1 Liter bottles | Class II | Terminated |
| D-0859-2021 | 08-20-2021 | Occular Allergy Blend 87% Alcohol; In Equal Parts of Apis Mellifica 7x Allium Cepa 7x Euphrasia Officinalis 7X Sabadilla 7X, WHP Homeopathic Medicine For Manufacturing Only, 500 ml. Manufcatured by Washington Homeopathic Products 260JR Hawvermale Way, Berkeley Springs WV 25411 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2/500 mL bottles | Class II | Terminated |
| D-0882-2021 | 08-20-2021 | Z-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Baryta Carbonica 10X, Chromium Sulphuricum 10X, Crataegus Oxyacantha 10X, Digitalis Purpurea 10X, Manganum Metallicum 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2 1/liter bottle | Class II | Terminated |
| D-0894-2021 | 08-20-2021 | Aconitum nap Fear* 20% Alcohol HPUS: 6X, packaged in 50mL & 8 oz containers Aconitum nap Fear* 20% Alcohol HPUS: 7X, 12X, packaged in 15mL containers WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 562 bottles | Class II | Terminated |
| D-0871-2021 | 08-20-2021 | Kali Sulphuricum 3X, 960ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Use Only. Manufactured by Washington Homeopathic Products 260JR hawvermale Way Berkeley Springs WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 12/960 mL bottles | Class II | Terminated |
| D-0895-2021 | 08-20-2021 | Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 562 bottles | Class II | Terminated |
| D-0872-2021 | 08-20-2021 | Althaea Officinalis 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 10 bottles | Class II | Terminated |
| D-0870-2021 | 08-20-2021 | La Core LCL-2-0191 Blend, 149,980ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Only, Liter LCL-2-0191-Bend: 12% Lycopodium Clavatum 10X, 12% Carbo Vegetabilis 16X, 12% Natrum Muriaticum 9X, 12% Calcarea Carbonica 12X, 10% Hypothalamus 30X, 6% Pituitarum Posterium 12X, 6% Pituitarum Posterium 30C, 3% Natrum Phosphoricum 12X, 3% Graphites 30X, 3# Agnus Castus 6X, 3% Thiosinaminum 8X, 3% Phytolacca Decandra 12X, 3% Magnesia Phosphorica 10X, 3% Ornithogalum Umbellatum 6X, 3% Chelidonium Majus 6X, 3% Quercus Robur 14X, 3% Nux Vomica 30X, Manufactured by Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 2/149,980 mL bottles | Class II | Terminated |
| D-0865-2021 | 08-20-2021 | Cistus Canadensis 6X, 10X, 15X, 30X, Coldness* Sucrose/Lactose Pills, 6X Packaged as a) 1 OZ, UPC 7 40640 28177 2, b) 4 dr, UPC 7 40640 28173 4; 10X Packaged as c) 4 dr; 15X Packaged as d) 1 OZ; 30X Packaged as e) 2 Dram, UPC 7 40640 28171 0, f) 4 dr, UPC 7 40640 28175 8; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411 | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 17 bottles | Class II | Terminated |
| D-0861-2021 | 08-20-2021 | Haloderm Homeopathic Blend, For Manufacturing Use Only, 1,000 ml 20% Alcohol, Contains: Dulcamara 10x, Nitricum Acidum 12x, Thuja Occidentalis 10x, Antimonium Crudum 12x, Calcarea Cadbonica 12x, Silicea 12x, WHP Homeopathic Medicine, FOr Manufacturing Use Only. 1.957 kg Lactose Manufactured by Wasington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411. Marketed by: Health Specialty | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 3 Liter bottles | Class II | Terminated |
| D-0888-2021 | 08-20-2021 | ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus Toxicodendron 10X, Aurum Metallicum 10X, Iris Versicolor 10X, Lycopodium Clavatum 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%, Manufactured for Optimal Health Dimensions, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 25411, | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Washington Homeopathic Products, Inc. / 1 1/liter | Class II | Terminated |
| D-0773-2021 | 08-19-2021 | Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 Package NDCs: 0002-1433-01; 0002-1433-80; 0002-1433-61; 0002-1434-01; 0002-1434-80; 0002-1434-61; 0002-2236-01; 0002-2236-80; 0002-2236-61; 0002-3182-01; 0002-3182-80; 0002-3182-61 | Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product. | Eli Lilly & Company / 119,539 4-packs | Class II | Terminated |
| D-0794-2021 | 08-19-2021 | Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-002-01 Package NDCs: 42858-001-01; 42858-001-10; 42858-002-01; 42858-002-10; 42858-003-01; 42858-004-01; 42858-005-01 | Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle | Rhodes Pharmaceuticals, L.P. / 55,344/100 count bottles | Class II | Terminated |
| D-0804-2021 | 08-18-2021 | Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy | Lack of Assurance of Sterility | Prescription Labs Inc dba Greenpark / 350 bottles | Class II | Terminated |
| D-0819-2021 | 08-18-2021 | X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2 | Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. | Phe Inc / 15000 packets | Class I | Completed |
| D-0754-2021 | 08-17-2021 | Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01 | A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles. | RemedyRepack Inc. / 4 | Class II | Terminated |
| D-0055-2022 | 08-13-2021 | BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0056-2022 | 08-13-2021 | CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0053-2022 | 08-13-2021 | ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0063-2022 | 08-13-2021 | MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0050-2022 | 08-13-2021 | TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0051-2022 | 08-13-2021 | VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0049-2022 | 08-13-2021 | TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
