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-1477-2022 | 06-07-2022 | MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72. | Microbial Contamination of Non-Sterile Products. | Plastikon Healthcare LLC / 7,700 cups | Class I | Terminated |
| D-1492-2022 | 06-07-2022 | CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 7,200 ampoules | Class II | Terminated |
| D-1478-2022 | 06-07-2022 | Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73 | Microbial Contamination of Non-Sterile Products. | Plastikon Healthcare LLC / 220,500 cups | Class I | Terminated |
| D-1483-2022 | 06-07-2022 | Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 88,500 cups | Class II | Terminated |
| D-1494-2022 | 06-07-2022 | CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-321-05 UPC 8 60003 67146 7 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 1,464 ampoules | Class II | Terminated |
| D-1484-2022 | 06-07-2022 | Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6738-70 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 290,270 cups | Class II | Terminated |
| D-1480-2022 | 06-07-2022 | MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73. | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 502,600 cups | Class II | Terminated |
| D-1486-2022 | 06-07-2022 | Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6820-76 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 3,507,740 cups | Class II | Terminated |
| D-1490-2022 | 06-07-2022 | GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152. NDC 0904-6844-70 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 280,500 cups | Class II | Terminated |
| D-1481-2022 | 06-07-2022 | MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72. | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 92,200 cups | Class II | Terminated |
| D-1476-2022 | 06-07-2022 | MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73. | Microbial Contamination of Non-Sterile Products | Plastikon Healthcare LLC / 24,400 cups | Class I | Terminated |
| D-1488-2022 | 06-07-2022 | Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6740-70 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 217,700 cups | Class II | Terminated |
| D-1479-2022 | 06-07-2022 | Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73 | Microbial Contamination of Non-Sterile Products. | Plastikon Healthcare LLC / 43,200 cups | Class I | Terminated |
| D-1482-2022 | 06-07-2022 | Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 521,700 cups | Class II | Terminated |
| D-1491-2022 | 06-07-2022 | GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6980-72 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 246,200 cups | Class II | Terminated |
| D-1485-2022 | 06-07-2022 | Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Plastikon Healthcare LLC / 848,500 cups | Class II | Terminated |
| D-1161-2022 | 06-06-2022 | Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1 Package NDCs: 72789-163-90; 72789-164-90; 72789-165-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | PD-Rx Pharmaceuticals, Inc. / 1441 bottles | Class II | Terminated |
| D-1163-2022 | 06-06-2022 | Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5 Package NDCs: 72789-163-90; 72789-164-90; 72789-165-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | PD-Rx Pharmaceuticals, Inc. / 1320 bottles | Class II | Terminated |
| D-1162-2022 | 06-06-2022 | Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-164-90 UPC 3 72789 16490 8 Package NDCs: 72789-163-90; 72789-164-90; 72789-165-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | PD-Rx Pharmaceuticals, Inc. / 687 bottles | Class II | Terminated |
| D-1176-2022 | 06-03-2022 | Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40. Package NDCs: 62756-017-40; 62756-015-40; 62756-016-40 | CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery. | SUN PHARMACEUTICAL INDUSTRIES INC / 27 vials | Class II | Terminated |
| D-1153-2022 | 06-03-2022 | Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, 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 62756-015-40. Package NDCs: 62756-017-40; 62756-015-40; 62756-016-40 | CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities. | SUN PHARMACEUTICAL INDUSTRIES INC / 97,450 vials | Class II | Terminated |
| D-1155-2022 | 06-03-2022 | Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles. | Failed Tablet/Capsule Specification; oversized tablet found in a bottle | SUN PHARMACEUTICAL INDUSTRIES INC / 4608 bottles | Class II | Terminated |
| D-1296-2022 | 05-26-2022 | Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua. C.P. 33880, ASIN B084L2XM3Z, UPC 3166557819586 | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac. | Amazon.com, Inc. / 35,622 cartons | Class I | Terminated |
| D-1295-2022 | 05-26-2022 | Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B092P4615M, UPC 7 501031 111190 | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac. | Amazon.com, Inc. / 2,441 bottles | Class I | Terminated |
| D-1297-2022 | 05-26-2022 | Artri King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B084KSV12L, UPC 7 501031 111190 | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac. | Amazon.com, Inc. / 15,087 bottles | Class I | Terminated |
| D-0987-2022 | 05-24-2022 | B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations, LLC, 116 Research Drive, Bethlehem, PA 18015, P/N: 234-15523 | Lack of Assurance of Sterility | US Specialty Formulations LLC / 1992 vials | Class II | Terminated |
| D-0986-2022 | 05-24-2022 | Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229 | Lack of Assurance of Sterility | US Specialty Formulations LLC / 781 vials | Class II | Terminated |
| D-0991-2022 | 05-24-2022 | Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15 Package NDCs: 0363-3233-15 | Microbial contamination of non-sterile product. | Grato Holdings, Inc. / 31,872 bottles | Class II | Terminated |
| D-0989-2022 | 05-24-2022 | Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. NDC 11822-3644-3 Package NDCs: 11822-3644-3 | Microbial contamination of non-sterile product. | Grato Holdings, Inc. / 16,374 bottles | Class II | Terminated |
| D-1159-2022 | 05-24-2022 | Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled with UPC 7 501031 111190 and UPC 6 09002 40885, and b) 2 pack of 100-count bottles per carton UPC 3 72426 01434 | Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims. | Walmart Inc / 1308 bottles total | Class II | Completed |
| D-0990-2022 | 05-24-2022 | Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15 | Microbial contamination of non-sterile product. | Grato Holdings, Inc. / 50,640 bottles | Class II | Terminated |
| D-1158-2022 | 05-24-2022 | Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bottles, UPC 7 501031 12705. | Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims. | Walmart Inc / 1308 bottles total | Class II | Completed |
| D-1157-2022 | 05-24-2022 | Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800, Mexico, D.F., UPC 7 501031 111190. | Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation. | Walmart Inc / 1308 bottles total | Class I | Completed |
| D-1166-2022 | 05-23-2022 | Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous Use, 4 prefilled syringes, each containing 284 mg of inotersen, (equivalent to 300 mg inotersen sodium in 1.5 ml of solution), Distributed by Sobi, Inc. Inc Waltham MA 02451, NDC: 72126-007-01 | Superpotent: High Out of specification (OOS) test result for percent label claim (%LC). | Akcea Therapeutics, Inc. / 450 cartons | Class I | Terminated |
| D-0972-2022 | 05-18-2022 | Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-933-05 1000 film coated tablets NDC 64380-933-08 Package NDCs: 64380-933-04; 64380-933-05; 64380-933-08; 64380-934-04; 64380-934-05; 64380-934-08; 64380-935-04; 64380-935-05; 64380-935-08 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Strides Pharma Inc. / 200407 bottles | Class II | Terminated |
| D-0973-2022 | 05-18-2022 | Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-08 Package NDCs: 64380-933-04; 64380-933-05; 64380-933-08; 64380-934-04; 64380-934-05; 64380-934-08; 64380-935-04; 64380-935-05; 64380-935-08 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Strides Pharma Inc. / 381456 bottles | Class II | Terminated |
| D-0974-2022 | 05-18-2022 | Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08 Package NDCs: 64380-933-04; 64380-933-05; 64380-933-08; 64380-934-04; 64380-934-05; 64380-934-08; 64380-935-04; 64380-935-05; 64380-935-08 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Strides Pharma Inc. / 96966 bottles | Class II | Terminated |
| D-0962-2022 | 05-18-2022 | Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 65590 syringes | Class II | Terminated |
| D-0969-2022 | 05-18-2022 | Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 181560 syringes | Class II | Terminated |
| D-0951-2022 | 05-18-2022 | Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 30180 syringes | Class II | Terminated |
| D-0959-2022 | 05-18-2022 | Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 30,290 syringes | Class II | Terminated |
| D-0953-2022 | 05-18-2022 | Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 134415 syringes | Class II | Terminated |
| D-0967-2022 | 05-18-2022 | Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 585660 syringes | Class II | Terminated |
| D-0955-2022 | 05-18-2022 | Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 32,550 syringes | Class II | Terminated |
| D-0961-2022 | 05-18-2022 | Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 115640 syringes | Class II | Terminated |
| D-0965-2022 | 05-18-2022 | Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 57810 syringes | Class II | Terminated |
| D-0950-2022 | 05-18-2022 | 8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 13612 syringes | Class II | Terminated |
| D-0966-2022 | 05-18-2022 | Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 76860 syringes | Class II | Terminated |
| D-0964-2022 | 05-18-2022 | Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 3587 bags | Class II | Terminated |
| D-0954-2022 | 05-18-2022 | Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 3532 bags | Class II | Terminated |
| D-0957-2022 | 05-18-2022 | Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 2795 syringes | Class II | Terminated |
| D-0958-2022 | 05-18-2022 | Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe, 5 x 30 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 6210 syringes | Class II | Terminated |
| D-0963-2022 | 05-18-2022 | Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-902-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 64450 syringes | Class II | Terminated |
| D-0956-2022 | 05-18-2022 | Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-03 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 6150 syringes | Class II | Terminated |
| D-0960-2022 | 05-18-2022 | Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 107530 syringes | Class II | Terminated |
| D-0968-2022 | 05-18-2022 | Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 604080 syringes | Class II | Terminated |
| D-0952-2022 | 05-18-2022 | EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-544-10 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 35850 syringes | Class II | Terminated |
| D-0988-2022 | 05-18-2022 | Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01 | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing | Teva Pharmaceuticals USA Inc / 3109 cartons | Class III | Terminated |
| D-0976-2022 | 05-17-2022 | AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g) | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / N/A | Class II | Ongoing |
| D-0981-2022 | 05-17-2022 | Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients, Net Wt. 5 oz (141 g), Distributed by Johnson & Johnson Consumer, Inc. Skillman, NJ 08558, UPC 3 81137-001530 7 | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-0980-2022 | 05-17-2022 | Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96536 9 | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / N/A | Class II | Ongoing |
| D-0979-2022 | 05-17-2022 | Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96537 6 | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / N/A | Class II | Ongoing |
| D-0977-2022 | 05-17-2022 | AMBI Skincare Fade Cream Oily Skin New & Improved, Net Wt. 2 OZ (56g) | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / N/A | Class II | Ongoing |
| D-0975-2022 | 05-17-2022 | Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer With Broad Spectrum SPF 30 Sunscreen, Net Wt. 1.7 FL. OZ. (50 mL) | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / Unknown | Class II | Ongoing |
| D-0978-2022 | 05-17-2022 | AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment With Oat and Sea Whip, Net Wt. 5 OZ. (141 g) | cGMP deviations: product stored outside of labeled temperature requirements. | Family Dollar Stores, Llc. / N/A | Class II | Ongoing |
| D-0888-2022 | 05-13-2022 | Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90 | CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. | Direct Rx / 16 bottles | Class II | Terminated |
| D-0896-2022 | 05-13-2022 | Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13. Package NDCs: 49702-255-37; 49702-226-13; 49702-227-13; 49702-228-13 | Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026. | GlaxoSmithKline LLC / 328 bottles | Class III | Terminated |
| D-1131-2022 | 05-13-2022 | Influenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C, 12C, 30C 1M, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 6,406 glass amber bottles | Class II | Terminated |
| D-1141-2022 | 05-13-2022 | Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 2 glass amber bottles | Class II | Terminated |
| D-1127-2022 | 05-13-2022 | Candida Albicans, Potency: 9C, 10C, 12C, 13C, 14C 15C 16C, 19C, 24C, 25C, 26C, 30C, 200C, 14X, 15X, 16X, 20X, 288X, 30X, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 1,047 glass amber bottles | Class II | Terminated |
| D-1137-2022 | 05-13-2022 | Streptococcinum, Potency: 8C, 9C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 5 glass amber bottles | Class II | Terminated |
| D-1128-2022 | 05-13-2022 | Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15C, 25C, 30C, 13X, 27X, 30X, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 134 glass amber bottles | Class II | Terminated |
| D-1125-2022 | 05-13-2022 | Anthracinum, Potency: 6C, 7C, 8C, 9C, 12C, 14C, 30C, 200C, 11X, 14X, 30X Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 219 glass amber bottles | Class II | Terminated |
| D-1136-2022 | 05-13-2022 | Pyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, OTC, Liquid Pellets, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 6,782 glass amber bottles | Class II | Terminated |
| D-1135-2022 | 05-13-2022 | Proteus, Potency: 7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, 200C, OTC, Liquid Pellets, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 109 glass amber bottles | Class II | Terminated |
| D-1140-2022 | 05-13-2022 | Tuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 4 glass amber bottles | Class II | Terminated |
| D-1129-2022 | 05-13-2022 | Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 206 glass amber bottles | Class II | Terminated |
| D-1133-2022 | 05-13-2022 | Morbillinum, Potency:7C, 8C, 9C, 10C 12C, 13C, 15C, 20C, 21C, 30C, 200 C,Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 72 glass amber bottles | Class II | Terminated |
| D-1138-2022 | 05-13-2022 | Syphilinum, Potency: 9C, 30C, 200C, 10X, 12X, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 15 glass amber bottles | Class II | Terminated |
| D-1130-2022 | 05-13-2022 | Diphtherinum, Potency: 14C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411, | cGMP deviations | Washington Homeopathic Products, Inc. / 7 glass amber bottles | Class II | Terminated |
| D-1132-2022 | 05-13-2022 | Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 49 glass amber bottles | Class II | Terminated |
| D-1139-2022 | 05-13-2022 | Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 15 glass amber bottles | Class II | Terminated |
| D-1134-2022 | 05-13-2022 | Pertussinum, Potency: 19C, 30C, 200C, 1M, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 375 glass amber bottles | Class II | Terminated |
| D-1126-2022 | 05-13-2022 | Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411 | cGMP deviations | Washington Homeopathic Products, Inc. / 5 glass amber bottles | Class II | Terminated |
| D-1142-2022 | 05-11-2022 | Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote, Product Code 9999D361-250: (b) 1 U.S. gallon, Product Code 9999D361-001: A.P. Nonweiler Co., Inc., 3321 County Road A, Oshkosh, WI 54901. | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | A.P. Nonweiler / 833 gallons | Class II | Ongoing |
| D-0893-2022 | 05-11-2022 | Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540 Package NDCs: 72189-290-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Direct Rx / 11 bottles | Class II | Terminated |
| D-0895-2022 | 05-11-2022 | Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540 Package NDCs: 72189-289-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Direct Rx / 11 bottles | Class II | Terminated |
| D-0894-2022 | 05-11-2022 | Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540 Package NDCs: 72189-297-90 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Direct Rx / 6 bottles | Class II | Terminated |
| D-0992-2022 | 05-11-2022 | Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60. | Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing. | Teva Pharmaceuticals USA Inc / 4224 cartons | Class I | Terminated |
| D-1148-2022 | 05-10-2022 | Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668 | Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol. | AMS Packaging Inc / unknown | Class II | Ongoing |
| D-0982-2022 | 05-10-2022 | Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936. Package NDCs: 0078-0911-05; 0078-0911-12; 0078-0911-95; 0078-0911-94 | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation / 1,187,092 vials | Class III | Terminated |
| D-0984-2022 | 05-10-2022 | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936. Package NDCs: 0078-0911-05; 0078-0911-12; 0078-0911-95; 0078-0911-94 | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation / 279,179 vials | Class III | Terminated |
| D-0983-2022 | 05-10-2022 | Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421. | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation / 1,253,862 vials | Class III | Terminated |
| D-0985-2022 | 05-10-2022 | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421. | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation / 279,179 vials | Class III | Terminated |
| D-0939-2022 | 05-09-2022 | NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0083-00. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 8982 vials | Class II | Completed |
| D-0927-2022 | 05-09-2022 | Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine 0.02 mg/mL, Packaged as a)2.5 mL Multi-Dose vial, NDC 73198-0001-03; b) 10 mL Multi-Dose vial, NDC 73198-0001-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1703 vials | Class II | Completed |
| D-0935-2022 | 05-09-2022 | Magnesium Chloride, 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0072-30. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1597 vials | Class II | Completed |
| D-0912-2022 | 05-09-2022 | Testosterone Cypionate 200 mg/mL in Sesame Oil, Packaged in a) 5 mL Multi-Dose vial NDC, 73198-0055-05; b) 10 mL Multi-Dose vial NDC 73198-0055-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 33 vials | Class II | Completed |
| D-0926-2022 | 05-09-2022 | Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0112-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2441 vials | Class II | Completed |
| D-0931-2022 | 05-09-2022 | Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0099-30 | Lack of assurance of sterility. | Olympia Compounding Pharmacy dba Olympia Pharmacy / 310 vials | Class II | Completed |
