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 July 04, 2025 and include a total of 16930 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0089-2017 | 07-17-2015 | rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 6970 syringes | Class II | Terminated |
| D-0051-2017 | 07-17-2015 | HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3352. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 4860 syringes | Class II | Terminated |
| D-0032-2017 | 07-17-2015 | Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 210 syringes | Class II | Terminated |
| D-0027-2017 | 07-17-2015 | Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 660 syringes | Class II | Terminated |
| D-0067-2017 | 07-17-2015 | lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3384. | Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 512 syringes | Class II | Terminated |
| D-0083-2017 | 07-17-2015 | neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 250 syringes | Class II | Terminated |
| D-0025-2017 | 07-17-2015 | atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 4407 syringes | Class II | Terminated |
| D-0075-2017 | 07-17-2015 | midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356. | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. | Pharmedium Services, LLC / 26079 syringes | Class II | Terminated |
| D-1345-2015 | 07-17-2015 | buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86 Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13 | Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications. | Sun Pharma Global Fze / 35,235 bottles | Class III | Terminated |
| D-1423-2015 | 07-16-2015 | Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01 | Chemical Contamination; benzophenone leached from the product label varnish | Mutual Pharmaceutical Company, Inc. / 5472 bottles | Class III | Terminated |
| D-1424-2015 | 07-16-2015 | Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01 | Chemical Contamination; benzophenone leached from the product label varnish | Mutual Pharmaceutical Company, Inc. / 14,112 bottles | Class III | Terminated |
| D-1425-2015 | 07-16-2015 | Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01 | Chemical Contamination; benzophenone leached from the product label varnish | Mutual Pharmaceutical Company, Inc. / 10,080 bottles | Class III | Terminated |
| D-0785-2016 | 07-16-2015 | Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304. | Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml. | Safecor Health, LLC / 23 cups | Class II | Terminated |
| D-1422-2015 | 07-16-2015 | Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01 | Chemical Contamination; benzophenone leached from the product label varnish | Mutual Pharmaceutical Company, Inc. / 63,975 bottles | Class III | Terminated |
| D-1421-2015 | 07-16-2015 | Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01 | Chemical Contamination; benzophenone leached from the product label varnish | Mutual Pharmaceutical Company, Inc. / 97,859 bottles | Class III | Terminated |
| D-1420-2015 | 07-16-2015 | Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01 | Chemical Contamination; benzophenone leached from the product label varnish | Mutual Pharmaceutical Company, Inc. / 25,272 bottles | Class III | Terminated |
| D-1322-2015 | 07-15-2015 | SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0573-02 Package NDCs: 0135-0573-02; 0135-0573-03; 0135-0572-02; 0135-0572-03 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 81,376 tubes | Class II | Terminated |
| D-1323-2015 | 07-15-2015 | SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02 Package NDCs: 0135-0548-02; 0135-0548-01; 0135-0547-02; 0135-0575-01 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 335,676 tubes | Class II | Terminated |
| D-1319-2015 | 07-15-2015 | biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01 Package NDCs: 0135-0557-01; 0135-0557-02; 0135-0558-01 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 111,892 tubes | Class II | Terminated |
| D-1318-2015 | 07-15-2015 | biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 Package NDCs: 0135-0557-01; 0135-0557-02; 0135-0558-01; 0135-0487-02; 0135-0487-01 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 366,192 tubes | Class II | Terminated |
| D-1324-2015 | 07-15-2015 | SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 Package NDCs: 0135-0548-02; 0135-0548-01; 0135-0547-02; 0135-0575-01 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 325,504 tubes | Class II | Terminated |
| D-1317-2015 | 07-15-2015 | biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 30,516 tubes | Class II | Terminated |
| D-1320-2015 | 07-15-2015 | biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 50,860 tubes | Class II | Terminated |
| D-1321-2015 | 07-15-2015 | SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0572-02 Package NDCs: 0135-0573-02; 0135-0573-03; 0135-0572-02; 0135-0572-03 | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. | GlaxoSmithkline Consmer Healthcare / 50,860 tubes | Class II | Terminated |
| D-1371-2015 | 07-14-2015 | Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA | Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station | KVK-Tech, Inc. / 9,696 bottles (100-count), 972 bottles (1000-count) | Class III | Terminated |
| D-1278-2015 | 07-13-2015 | Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30 | Failed dissolution specifications | Purdue Pharma L.P. / 6,264 cartons (30 sublingual tablets in 1 carton) | Class III | Terminated |
| D-1286-2015 | 07-13-2015 | Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37 | Subpotent drug | Perrigo Israel Pharmaceuticals / 158,268 tubes | Class III | Terminated |
| D-0664-2016 | 07-13-2015 | Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida | Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling. | Life and More LLC / 783 bottles | Class I | Ongoing |
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
