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-0765-2022 | 03-29-2022 | IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11. | Presence of Particulate Matter: Product was found to contain silica and iron oxide | Teva Pharmaceuticals USA Inc / 1565 vials | Class I | Terminated |
| D-0769-2022 | 03-28-2022 | Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delayed-Release Capsules, 15mg, Generic for Prevacid, 90-Count Bottle, Manufacturer: Dr Reddy's Laboratories Limited, NDC 68788-6390-09 | Out of specification results observed in dissolution during long term stability testing. | Preferred Pharmaceuticals, Inc. / 791 bottles of 90 - Count | Class II | Terminated |
| D-0771-2022 | 03-24-2022 | Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican's Solution, Mfg: Teligent Pharma, Inc., NDC 68788-7406-03 | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program. | Preferred Pharmaceuticals, Inc. / 41 Tubes | Class II | Terminated |
| D-0870-2022 | 03-24-2022 | MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73. | CGMP Deviations: Failure to properly investigate failed microbial testing. | Plastikon Healthcare LLC / 5,400 Unit Dose cups | Class II | Completed |
| D-0868-2022 | 03-24-2022 | Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73. | Microbial Contamination of Non-Sterile Products | Plastikon Healthcare LLC / 23,300 Unit Dose cups | Class I | Completed |
| D-0867-2022 | 03-24-2022 | MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73. | Microbial Contamination of Non-Sterile Products | Plastikon Healthcare LLC / 14,100 Unit Dose cups | Class I | Completed |
| D-0869-2022 | 03-24-2022 | Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76. | CGMP Deviations: Failure to properly investigate failed microbial testing. | Plastikon Healthcare LLC / 121,800 Unit Dose cups | Class II | Completed |
| D-0871-2022 | 03-24-2022 | Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73. | CGMP Deviations: Failure to properly investigate failed microbial testing. | Plastikon Healthcare LLC / 106,400 Unit Dose cups | Class II | Completed |
| D-0773-2022 | 03-24-2022 | Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01 | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program. | Preferred Pharmaceuticals, Inc. / 528 bottles | Class II | Terminated |
| D-0728-2022 | 03-23-2022 | GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 6017 vials | Class II | Terminated |
| D-0738-2022 | 03-23-2022 | Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90. Package NDCs: 55111-398-30; 55111-398-60; 55111-398-90; 55111-398-01; 55111-398-05; 55111-398-79; 55111-399-30; 55111-399-60; 55111-399-90; 55111-399-01; 55111-399-05; 55111-399-79 | Failed Dissolution Specifications; during long term stability testing. | Dr. Reddy's Laboratories, Inc. / 7,703 bottles | Class II | Terminated |
| D-0737-2022 | 03-23-2022 | Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India Package NDCs: 55111-398-30; 55111-398-60; 55111-398-90; 55111-398-01; 55111-398-05; 55111-398-79; 55111-399-30; 55111-399-60; 55111-399-90; 55111-399-01; 55111-399-05; 55111-399-79 | Failed Dissolution Specifications; during long term stability testing. | Dr. Reddy's Laboratories, Inc. / 8,352 bottles (30-count), 1,368 bottles (90-count) | Class II | Terminated |
| D-0768-2022 | 03-23-2022 | Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED Pharmaceuticals, Inc., The Physician's Solution, NDC 68788-7768-01 | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program. | Preferred Pharmaceuticals, Inc. / 1568 bottles | Class II | Terminated |
| D-0731-2022 | 03-23-2022 | TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML Formula ID 136164; b) (RM) 10 ML Formula ID 115962; APS Phar | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 73 vials | Class II | Terminated |
| D-0733-2022 | 03-23-2022 | TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable, Packaged in a multi dose 10ml vial, Formula ID 115498, APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 0 | Class II | Terminated |
| D-0730-2022 | 03-23-2022 | TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 846 vials | Class II | Terminated |
| D-0735-2022 | 03-23-2022 | TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 17 vials | Class II | Terminated |
| D-0732-2022 | 03-23-2022 | TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 620 vials | Class II | Terminated |
| D-0729-2022 | 03-23-2022 | (CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 1843 vials | Class II | Terminated |
| D-0734-2022 | 03-23-2022 | TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy | Lack of sterility assurance. | Drug Depot, Inc., dba APS Pharmacy / 24 vials | Class II | Terminated |
| D-0760-2022 | 03-21-2022 | quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1 | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 1104 bottles | Class II | Terminated |
| D-0755-2022 | 03-21-2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0222-23 | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 160 bottles | Class II | Terminated |
| D-0757-2022 | 03-21-2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23. | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 265 bottles | Class II | Terminated |
| D-0756-2022 | 03-21-2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles, Rx Only Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0220-23. | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 1364 bottles | Class II | Terminated |
| D-0759-2022 | 03-21-2022 | quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1 | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 21108 bottles | Class II | Terminated |
| D-0751-2022 | 03-21-2022 | The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (500 mL, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC Code 714132000714. | Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC | Revive Personal Products Company / 6156 bottles | Class II | Terminated |
| D-0761-2022 | 03-21-2022 | Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 . | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 195 bottles | Class II | Terminated |
| D-0754-2022 | 03-21-2022 | Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-3112-23. | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 53 bottles | Class II | Terminated |
| D-0753-2022 | 03-21-2022 | Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01. Package NDCs: 0185-0022-10; 0185-0022-01 | CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. | Sandoz, Inc / 7908 bottles(790,800 extended release tablets) | Class II | Terminated |
| D-0763-2022 | 03-21-2022 | SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-130-02 | Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine. | Adamis Pharmaceuticals Corporation / 25,103 cartons | Class I | Terminated |
| D-0764-2022 | 03-21-2022 | SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-131-02. | Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine. | Adamis Pharmaceuticals Corporation / 2,500 cartons | Class I | Terminated |
| D-0758-2022 | 03-21-2022 | quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9 | CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. | Pfizer Inc. / 2442 bottles | Class II | Terminated |
| D-0747-2022 | 03-18-2022 | NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of 1,10-phenanthroline, 6 mcg of Gentisic acid, 20 mg of D-Mannitol, and Nitrogen; and Vial 2, 1 Single dose vial of reaction buffer, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc., by: Gipharma S.r.l., Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40 Package NDCs: 69488-001-40 | Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies. | Advanced Accelerator Applications USA, Inc. / 14,089 kits | Class III | Terminated |
| D-0736-2022 | 03-17-2022 | Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01. Package NDCs: 13107-014-01; 13107-015-01 | Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room. | Aurolife Pharma, LLC / 4080 bottles | Class II | Terminated |
| D-1177-2022 | 03-16-2022 | Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA. Package NDCs: 60429-183-30; 60429-183-10; 60429-183-90; 60429-184-30; 60429-184-10; 60429-184-90; 60429-185-30; 60429-185-10; 60429-185-90; 60429-186-30; 60429-186-10; 60429-186-90 | CGMP Deviations | Golden State Medical Supply Inc. / 1,471 bottles | Class II | Ongoing |
| D-1180-2022 | 03-16-2022 | Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA. Package NDCs: 60429-183-30; 60429-183-10; 60429-183-90; 60429-184-30; 60429-184-10; 60429-184-90; 60429-185-30; 60429-185-10; 60429-185-90; 60429-186-30; 60429-186-10; 60429-186-90 | CGMP Deviations | Golden State Medical Supply Inc. / 1,424 bottles | Class II | Ongoing |
| D-1179-2022 | 03-16-2022 | Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA. Package NDCs: 60429-183-30; 60429-183-10; 60429-183-90; 60429-184-30; 60429-184-10; 60429-184-90; 60429-185-30; 60429-185-10; 60429-185-90; 60429-186-30; 60429-186-10; 60429-186-90 | CGMP Deviations | Golden State Medical Supply Inc. / 31,260 bottles | Class II | Ongoing |
| D-1178-2022 | 03-16-2022 | Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA. Package NDCs: 60429-183-30; 60429-183-10; 60429-183-90; 60429-184-30; 60429-184-10; 60429-184-90; 60429-185-30; 60429-185-10; 60429-185-90; 60429-186-30; 60429-186-10; 60429-186-90 | CGMP Deviations | Golden State Medical Supply Inc. / 9,058 | Class II | Ongoing |
| D-0726-2022 | 03-16-2022 | Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90 Package NDCs: 55111-124-30; 55111-124-60; 55111-124-90; 55111-124-05 | Failed Impurities/Degradation Specifications: Out of Specification results for related substance. | Dr. Reddy's Laboratories, Inc. / 28,068 bottles | Class III | Terminated |
| D-0696-2022 | 03-15-2022 | Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 159,994 tubes | Class II | Terminated |
| D-0689-2022 | 03-15-2022 | Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 161,331 tubes | Class II | Terminated |
| D-0683-2022 | 03-15-2022 | Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 13,905 tubes | Class II | Terminated |
| D-0672-2022 | 03-15-2022 | Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 35,180 bottles | Class II | Terminated |
| D-0693-2022 | 03-15-2022 | Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tubes, NDC 52565-122-30; c) 5 x 5 gram tubes, NDC 52565-122-07; Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310; Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 136,960 tubes | Class II | Terminated |
| D-0676-2022 | 03-15-2022 | Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 6850 tubes | Class II | Terminated |
| D-0673-2022 | 03-15-2022 | Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 72,826 tubes | Class II | Terminated |
| D-0694-2022 | 03-15-2022 | Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-008-14. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 100,256 tubes | Class II | Terminated |
| D-0692-2022 | 03-15-2022 | Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 30,497 bottles | Class II | Terminated |
| D-0677-2022 | 03-15-2022 | Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 54,897 tubes | Class II | Terminated |
| D-0686-2022 | 03-15-2022 | Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 355,672 tubes | Class II | Terminated |
| D-0703-2022 | 03-15-2022 | Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 6874 bottles | Class II | Terminated |
| D-0690-2022 | 03-15-2022 | Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 6431 bottles | Class II | Terminated |
| D-0669-2022 | 03-15-2022 | Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310 | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 43,218 bottles | Class II | Terminated |
| D-0682-2022 | 03-15-2022 | Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 151,975 tubes | Class II | Terminated |
| D-0698-2022 | 03-15-2022 | Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 112,769 bottles | Class II | Terminated |
| D-0671-2022 | 03-15-2022 | Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 105,200 tubes | Class II | Terminated |
| D-0704-2022 | 03-15-2022 | Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 48,907 tubes | Class II | Terminated |
| D-0701-2022 | 03-15-2022 | Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New Jersey 08310, NDC 52565-063-60. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 4532 tubes | Class II | Terminated |
| D-0680-2022 | 03-15-2022 | Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 36,018 bottles | Class II | Terminated |
| D-0705-2022 | 03-15-2022 | Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-341-35. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 49,081 tubes | Class II | Terminated |
| D-0699-2022 | 03-15-2022 | Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 482,003 tubes; 45,583 jars | Class II | Terminated |
| D-0670-2022 | 03-15-2022 | Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 207,933 tubes | Class II | Terminated |
| D-0687-2022 | 03-15-2022 | Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 43,956 tubes | Class II | Terminated |
| D-0691-2022 | 03-15-2022 | Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, 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 63739-998-67. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 21,323 tubes | Class II | Terminated |
| D-0674-2022 | 03-15-2022 | Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 81,883 tubes | Class II | Terminated |
| D-0685-2022 | 03-15-2022 | Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 7169 bottles | Class II | Terminated |
| D-0700-2022 | 03-15-2022 | Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 26,326 tubes | Class II | Terminated |
| D-0679-2022 | 03-15-2022 | Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 16,643 bottles | Class II | Terminated |
| D-0684-2022 | 03-15-2022 | Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 51,748 tubes | Class II | Terminated |
| D-0681-2022 | 03-15-2022 | Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-031-60. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 24,304 bottles | Class II | Terminated |
| D-0695-2022 | 03-15-2022 | Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 217,184 tubes | Class II | Terminated |
| D-0678-2022 | 03-15-2022 | Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 13,989 tubes | Class II | Terminated |
| D-0688-2022 | 03-15-2022 | Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-033-50. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 35,185 tubes | Class II | Terminated |
| D-0702-2022 | 03-15-2022 | Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810, NDC 70512-036-30. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 31,489 tubes | Class II | Terminated |
| D-0675-2022 | 03-15-2022 | Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 36,426 tubes | Class II | Terminated |
| D-0697-2022 | 03-15-2022 | Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 721,225 tubes; 90,893 jars | Class II | Terminated |
| D-0741-2022 | 03-14-2022 | TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10. | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | Vitae Enim Vitae Scientific, Inc. / 722 boxes | Class II | Terminated |
| D-0742-2022 | 03-14-2022 | PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc. Package NDCs: 72516-024-25; 72516-024-10 | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | Vitae Enim Vitae Scientific, Inc. / a) 2,098 boxes; b) 700 boxes | Class II | Terminated |
| D-0744-2022 | 03-14-2022 | PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC. Package NDCs: 42494-416-25; 42494-416-03; 42494-415-25; 42494-415-03 | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | Vitae Enim Vitae Scientific, Inc. / a) 18,531 boxes; b) 4,492 boxes | Class II | Terminated |
| D-0743-2022 | 03-14-2022 | PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC. Package NDCs: 42494-416-25; 42494-416-03; 42494-415-25; 42494-415-03 | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | Vitae Enim Vitae Scientific, Inc. / a) 21,501 boxes; b) 4,846 boxes | Class II | Terminated |
| D-0708-2022 | 03-14-2022 | Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-475-15 | Defective container | Athenex Pharma Solutions, LLC / 9,800 bags | Class II | Terminated |
| D-0707-2022 | 03-14-2022 | Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-476-15 | Defective container | Athenex Pharma Solutions, LLC / 5,320 bags | Class II | Terminated |
| D-0706-2022 | 03-14-2022 | Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-474-15 | Defective container | Athenex Pharma Solutions, LLC / 4,270 bags | Class II | Terminated |
| D-0710-2022 | 03-14-2022 | Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-494-15 | Defective container | Athenex Pharma Solutions, LLC / 1,800 bags | Class II | Terminated |
| D-0709-2022 | 03-14-2022 | Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-493-15 | Defective container | Athenex Pharma Solutions, LLC / 670 bags | Class II | Terminated |
| D-0712-2022 | 03-14-2022 | Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-814-15 | Defective container | Athenex Pharma Solutions, LLC / N/A | Class II | Terminated |
| D-0711-2022 | 03-14-2022 | Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-491-15 | Defective container | Athenex Pharma Solutions, LLC / 1,980 bags | Class II | Terminated |
| D-0749-2022 | 03-11-2022 | Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458. | Labeling: Label Mix-Up | DASH Pharmaceuticals LLC / 45,940 Unit Dose Cups | Class II | Terminated |
| D-0715-2022 | 03-10-2022 | ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.), NDC 74492-0002-1; b) 3785 mL/1 gallon NDC 74492-0002-2; c) 236 mL/8 oz. NDC 74492-0002-3; d) 473 mL/16 oz. NDC 74492-0002-4; Made in USA Rock Town Distillery, 1201 Main Street Little Rock, Arkansas 72202 | CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits. | Rock Town Distillery, Inc. / 35,468 containers | Class II | Terminated |
| D-0762-2022 | 03-10-2022 | Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07. Package NDCs: 33342-107-07; 33342-107-49; 33342-107-06; 33342-108-07; 33342-108-15; 33342-108-06; 33342-109-37; 33342-109-50 | FAILED CONTENT UNIFORMITY SPECIFICATIONS | Macleods Pharma Usa Inc / 4872 bottles | Class III | Terminated |
| D-0767-2022 | 03-08-2022 | Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06 Package NDCs: 59746-122-06; 59746-122-10; 59746-121-06; 59746-121-10 | Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride | Jubilant Cadista Pharmaceuticals, Inc. / 12,174 bottles | Class I | Terminated |
| D-0718-2022 | 03-08-2022 | Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00 | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2283 vials | Class II | Terminated |
| D-0724-2022 | 03-08-2022 | Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compounding Pharmacy Compounded by: Olympia Pharmacy Conroy Rd., Ste. 155, Orlando, FL 32835, NDC 73198-0082-00 Revised Label: Sincalide Lyophilized powder for reconstitution, 5mcg per multi dose vial, Each ML contains: 16.7% Mannitol, 3% Arginine, 1.5% Lysine, 0.9% Potassium Phosphate, 0.4% Methionine, 0.2% Edetate Disodium Dihydrate, 0.004% Sodium Metabisulfate, 0.0005% Polysorbate. Water for injection. Rx only, Olympia Pharmaceuticals NDC 73198-0082-00 | Super Potent and Failed Reconstitution Time | Olympia Compounding Pharmacy dba Olympia Pharmacy / 836 vials | Class II | Terminated |
| D-0720-2022 | 03-08-2022 | Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0004-10 | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy / 493 vials. | Class III | Terminated |
| D-0721-2022 | 03-08-2022 | T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL Multi-dose NDC 73198-0005-10; Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 0.5% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. | Super Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1093 vials | Class III | Terminated |
| D-0719-2022 | 03-08-2022 | NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate Monobasic USP, 0.42% Sodium Phosphate Dibasic USP, 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835 NDC: 73198-0083-00 | Product found to be Sub Potent or Exceeded reconstitution time | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2634 vials | Class II | Terminated |
| D-0722-2022 | 03-08-2022 | SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 2% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, Conroy Rd., Ste. 155, Orlando, FL 32835 | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1032 vials | Class III | Terminated |
| D-0723-2022 | 03-08-2022 | Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals Conroy Rd., Ste. 155, Orlando, FL 32835 NDC 73198-0080-30 | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1613 vials | Class III | Terminated |
| D-1216-2022 | 03-07-2022 | Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 191 vials | Class II | Ongoing |
| D-1193-2022 | 03-07-2022 | Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 32 vials | Class II | Ongoing |
