Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0559-2016 | 07-10-2015 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01 | cGMP Deviations | PD-Rx Pharmaceuticals, Inc. / 9 bottles | Class II | Terminated |
| D-1282-2015 | 07-09-2015 | Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01 | cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer | Mutual Pharmaceutical Company, Inc. / 20,892 bottles | Class II | Terminated |
| D-1280-2015 | 07-09-2015 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA | cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer | Mutual Pharmaceutical Company, Inc. / a) 96,640 bottles; b) 17,808 bottles | Class II | Terminated |
| D-1281-2015 | 07-09-2015 | Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA. | cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer | Mutual Pharmaceutical Company, Inc. / a) 39,036 bottles and b) 2,082 bottles | Class II | Terminated |
| D-1236-2015 | 07-07-2015 | Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-123-01 | Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing. | Kremers Urban Pharmaceuticals, Inc. / 16,832 Boxes | Class II | Terminated |
| D-1237-2015 | 07-07-2015 | Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-124-01 | Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing. | Kremers Urban Pharmaceuticals, Inc. / 16,504 Boxes | Class II | Terminated |
| D-1233-2015 | 07-06-2015 | Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet, OTC, Manufactured for Mission Pharmacal Company 10999 IH 10 West, Suite 1000 San Antonio, TX 78230 by Mission Pharmacal Company 38505 IH 10 West Boerne, TX 78006. NDC 0178-0320-12 | Subpotent Drug: menthol and methyl salicylate below specification | BioComp Pharma, Inc. / 40,000 sachets | Class III | Terminated |
| D-1240-2015 | 07-02-2015 | 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68 | Lack of assurance of sterility: Potential channel leaks near the threaded vial port. | Hospira Inc. / 314600 bags | Class II | Terminated |
| D-1165-2016 | 07-02-2015 | Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180 | Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine. | XTREME Z DISTRIBUTORS INC / 70,350 capsules | Class I | Ongoing |
| D-1419-2015 | 07-02-2015 | CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25 Drop Bags (UPC: 050428 448526) and b) 36 drop bags (UPC: 050428 476581), Over the Counter. Distributed by: CVS Pharmacy, Inc., One CVS Drive Woonsocket, RI 02895. | Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops. | Bestco, Inc. / a) 149,856 Bags; b) 19,200 Bags. | Class III | Terminated |
| D-1326-2015 | 07-02-2015 | 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03. Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors. | Baxter Healthcare Corp. / 189,912 containers | Class II | Terminated |
| D-1242-2015 | 06-30-2015 | KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49 Package NDCs: 0409-3793-19; 0409-3793-01; 0409-3793-25; 0409-3795-19; 0409-3795-01; 0409-3795-25; 0409-3796-19; 0409-3796-01; 0409-3796-25; 0409-3796-49 | Crystallization; identified as calcium salt of Ketorolac | Hospira Inc. / 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label) | Class II | Ongoing |
| D-1241-2015 | 06-30-2015 | KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49 Package NDCs: 0409-3793-19; 0409-3793-01; 0409-3793-25; 0409-3795-19; 0409-3795-01; 0409-3795-25; 0409-3796-19; 0409-3796-01; 0409-3796-25; 0409-3795-49 | Crystallization; identified as calcium salt of Ketorolac | Hospira Inc. / 12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label) | Class II | Ongoing |
| D-1287-2015 | 06-30-2015 | Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080-7, NDC 0135-0135-03) and c) 100 count (UPC 1-03-53100-91090-6, NDC 0135-0135-04) bottles, Distributed by: GlaxoSmithKline Consumer Healthcare L.P, Moon Township, PA 15108 | Failed Dissolution Specifications | GlaxoSmithkline Consmer Healthcare / 17,675 cases | Class III | Terminated |
| D-1217-2015 | 06-30-2015 | Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6. | Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point. | Mylan Pharmaceuticals Inc / 1068 bottles | Class II | Terminated |
| D-1239-2015 | 06-29-2015 | HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL | Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable | Qualitest Pharmaceuticals / 47,376 bottles | Class III | Terminated |
| D-1298-2015 | 06-26-2015 | SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 55 mL | Class II | Terminated |
| D-1308-2015 | 06-26-2015 | SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 67.5 mL | Class II | Terminated |
| D-1294-2015 | 06-26-2015 | SIU-Papaverine 30 mg/mL Inj., Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-10 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 32.5 mL | Class II | Terminated |
| D-1305-2015 | 06-26-2015 | SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-1540-18 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 555.5 mL | Class II | Terminated |
| D-1300-2015 | 06-26-2015 | SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 10 mL | Class II | Terminated |
| D-1311-2015 | 06-26-2015 | SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,NDC 99999-2011-17 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 113 mL | Class II | Terminated |
| D-1301-2015 | 06-26-2015 | SIU-Prostaglandin E1 20 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-3169-01 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 163 mL | Class II | Terminated |
| D-1302-2015 | 06-26-2015 | SIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2348-22 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 5 mL | Class II | Terminated |
| D-1290-2015 | 06-26-2015 | S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 98 mL | Class II | Terminated |
| D-1293-2015 | 06-26-2015 | SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 23 mL | Class II | Terminated |
| D-1309-2015 | 06-26-2015 | SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 75 mL | Class II | Terminated |
| D-1310-2015 | 06-26-2015 | SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13389-1152-36 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 55 mL | Class II | Terminated |
| D-1295-2015 | 06-26-2015 | SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.. | The Apothecary Shoppe LLC / 20 mL | Class II | Terminated |
| D-1235-2015 | 06-26-2015 | Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21. | Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. | American Health Packaging / 341 Cartons | Class III | Terminated |
| D-1299-2015 | 06-26-2015 | SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 2.5 mL | Class II | Terminated |
| D-1313-2015 | 06-26-2015 | SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / N/A | Class II | Terminated |
| D-1291-2015 | 06-26-2015 | SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 1200.4 mL | Class II | Terminated |
| D-1289-2015 | 06-26-2015 | S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1962-40 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 64 mL | Class II | Terminated |
| D-1304-2015 | 06-26-2015 | SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 2.5 mL | Class II | Terminated |
| D-1315-2015 | 06-26-2015 | SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 34 mL | Class II | Terminated |
| D-1303-2015 | 06-26-2015 | SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 55 mL | Class II | Terminated |
| D-1314-2015 | 06-26-2015 | SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 10 mL | Class II | Terminated |
| D-1292-2015 | 06-26-2015 | S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1701-19 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 25.3 mL | Class II | Terminated |
| D-1316-2015 | 06-26-2015 | S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 750 mL | Class II | Terminated |
| D-1297-2015 | 06-26-2015 | SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 378 mL | Class II | Terminated |
| D-1312-2015 | 06-26-2015 | SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 40 mL | Class II | Terminated |
| D-1307-2015 | 06-26-2015 | SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1747-39 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 5 mL | Class II | Terminated |
| D-1296-2015 | 06-26-2015 | SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 70 mL | Class II | Terminated |
| D-1306-2015 | 06-26-2015 | SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2913-85 | Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. | The Apothecary Shoppe LLC / 10 mL | Class II | Terminated |
| D-1831-2015 | 06-26-2015 | METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01. | Defective Container: Lids on unit dose cups are not fully qualified. | VistaPharm, Inc. / 84,100 Cups | Class III | Terminated |
| D-1288-2015 | 06-26-2015 | Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31. Package NDCs: 10631-115-69; 10631-115-31; 10631-116-69; 10631-116-31; 10631-117-69; 10631-117-31; 10631-118-69; 10631-118-31; 10631-133-69; 10631-133-31; 10631-134-69; 10631-134-31; 10631-002-31; 10631-003-31; 10631-004-31; 10631-005-31; 10631-006-31; 10631-007-31 | Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell. | Ranbaxy Inc. / 9,229 Boxes | Class II | Terminated |
| D-1283-2015 | 06-24-2015 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02 Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | Failed Impurities/Degradation Specifications: out of specification for unknown impurity | Teva Pharmaceuticals USA / 19,504 bottles | Class II | Terminated |
| D-1231-2015 | 06-23-2015 | CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL pharmacy II, 4909 W Park Blvd, Suite 177, Plano, TX 75093 --- NDC 88888-0043-31 | Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications. | Abrams Royal Pharmacy II, LLC / 30 count: 5 Bottles; 90 count: 2 Bottles | Class III | Terminated |
| D-1285-2015 | 06-23-2015 | Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01. | Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. | Actavis Laboratories, FL, Inc. / 11,445 Bottles | Class III | Terminated |
| D-0385-2016 | 06-22-2015 | c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL RINSE OR NEBULIZER, SOLUTIONS Rx PHARMACY, 2705 4TH AVENUE SOUTH, BIRMINGHAM, AL 35233 | Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules. | Solutions Rx Pharmacy / 11,712 capsules | Class II | Terminated |
| D1151-2015 | 06-18-2015 | Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21. | Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution. | Qualitest Pharmaceuticals / 2016 bottles | Class III | Terminated |
| D-1399-2015 | 06-15-2015 | Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 5 vials | Class II | Terminated |
| D-1386-2015 | 06-15-2015 | Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 2 vials | Class II | Terminated |
| D-1389-2015 | 06-15-2015 | Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 1 bottle | Class II | Terminated |
| D-1380-2015 | 06-15-2015 | Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 6 syringes | Class II | Terminated |
| D-1398-2015 | 06-15-2015 | Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 2 vials | Class II | Terminated |
| D-1403-2015 | 06-15-2015 | Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 5 vials | Class II | Terminated |
| D-1381-2015 | 06-15-2015 | Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 2 vials | Class II | Terminated |
| D-1390-2015 | 06-15-2015 | Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 58 bags | Class II | Terminated |
| D-1397-2015 | 06-15-2015 | Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 1 vial | Class II | Terminated |
| D-1384-2015 | 06-15-2015 | Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 2 vials | Class II | Terminated |
| D-1387-2015 | 06-15-2015 | Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 3 bottles | Class II | Terminated |
| D-1391-2015 | 06-15-2015 | 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 85 vials | Class II | Terminated |
| D-1385-2015 | 06-15-2015 | Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 4 vials | Class II | Terminated |
| D-1392-2015 | 06-15-2015 | Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 15 vials | Class II | Terminated |
| D-1393-2015 | 06-15-2015 | Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 2 vials | Class II | Terminated |
| D-1395-2015 | 06-15-2015 | Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 22 vials | Class II | Terminated |
| D-1388-2015 | 06-15-2015 | Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 88 bags | Class II | Terminated |
| D-1396-2015 | 06-15-2015 | Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 4 bags | Class II | Terminated |
| D-1383-2015 | 06-15-2015 | Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 4 vials | Class II | Terminated |
| D-1401-2015 | 06-15-2015 | Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 30 bags | Class II | Terminated |
| D-1382-2015 | 06-15-2015 | Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 5 vials | Class II | Terminated |
| D-1402-2015 | 06-15-2015 | Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 6 vials | Class II | Terminated |
| D-1404-2015 | 06-15-2015 | Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 6 vials | Class II | Terminated |
| D-1394-2015 | 06-15-2015 | Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 112 bags | Class II | Terminated |
| D-1400-2015 | 06-15-2015 | Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. | Liberty Drug & Surgical / 6 vials | Class II | Terminated |
| D-1330-2015 | 06-12-2015 | PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8. | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug. | GC Natural Nutrition, Inc. / 12,000-15,000 bottles (estimated) | Class I | Terminated |
| D-1056-2016 | 06-10-2015 | Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. | Vital Care Compounder / 54 vials | Class II | Terminated |
| D-1141-2015 | 06-10-2015 | NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31. | Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets. | AstraZeneca Pharmaceuticals LP / 34,524 bottles | Class II | Terminated |
| D-1054-2016 | 06-10-2015 | Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. | Vital Care Compounder / 39 vials | Class II | Terminated |
| D-1055-2016 | 06-10-2015 | Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS | Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. | Vital Care Compounder / 9 Vials | Class II | Terminated |
| D-1150-2015 | 06-10-2015 | OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., St. Louis, MO 63044, Distributed by Major Pharmaceuticals, Livonia, MI 48150, NDC 0904-6444-61. | Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets. | The Harvard Drug Group, LLC / 12,717 tablets | Class II | Terminated |
| D-0503-2016 | 06-08-2015 | TRI-EST Liquids, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / | Class II | Terminated |
| D-0486-2016 | 06-08-2015 | 2-DEOXY-D-GLUCOSE Powder, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0493-2016 | 06-08-2015 | ESTRIOL Face Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0504-2016 | 06-08-2015 | TRI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0499-2016 | 06-08-2015 | BI-EST Suspensions, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0502-2016 | 06-08-2015 | TRI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0487-2016 | 06-08-2015 | E3 CREAM, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0507-2016 | 06-08-2015 | HUMAN CHORIONIC GONADOTROPIC (HCG) Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0500-2016 | 06-08-2015 | BI-EST Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0494-2016 | 06-08-2015 | ESTRIOL Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0490-2016 | 06-08-2015 | ESTRIOL Vaginal Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0497-2016 | 06-08-2015 | BI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0492-2016 | 06-08-2015 | ESTRIOL Vaginal Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0489-2016 | 06-08-2015 | ESTRIOL Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0505-2016 | 06-08-2015 | METHYLFOLATE Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0498-2016 | 06-08-2015 | BI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
| D-0508-2016 | 06-08-2015 | HUMAN CHORIONIC GONADOTROPIC (HCG) Sublingual Drops, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Life Science Pharmacy Inc / unknown | Class II | Terminated |
