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-1038-2016 | 05-28-2016 | Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11 | Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels. | Par Pharmaceutical / 12,535 bottles | Class III | Terminated |
| D-0134-2017 | 05-26-2016 | Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC | Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione. | Taro Pharmaceuticals U.S.A., Inc. / 17,100 kits | Class III | Terminated |
| D-1464-2016 | 05-26-2016 | Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL. | Crystallization; Complaints that cream appears to have crystallized | Stratus Pharmaceuticals Inc / a) 12,345 tubes; b) 8,578 tubes | Class III | Completed |
| D-1036-2016 | 05-25-2016 | Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01 | Labeling: Incorrect or Missing Package Insert | Sandoz Inc / 3,048 bottles ( 304,800 tablets) | Class III | Terminated |
| D-1032-2016 | 05-23-2016 | Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC 0 00950 86006 8. | Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top. | Valeant Pharmaceuticals North America LLC / 3827 bottles | Class III | Terminated |
| D-1030-2016 | 05-23-2016 | Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32 | Failed Dissolution Specifications | Nostrum Laboratories, Inc. / 2839 bottles | Class II | Terminated |
| D-1441-2016 | 05-19-2016 | Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41 Package NDCs: 0054-0390-41; 0054-0390-63 | Failed Impurities/Degradation Specification; 9 month stability | West-Ward Columbus Inc / 1,182 bottles | Class III | Terminated |
| D-1031-2016 | 05-19-2016 | Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30. | Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing. | Galderma Laboratories, L.P. / 71,340 Bottles | Class III | Terminated |
| D-1047-2016 | 05-18-2016 | Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada | cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration | Attix Pharmaceuticals Inc / N/A | Class III | Terminated |
| D-1449-2016 | 05-18-2016 | Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01. | Failed Tablet/Capsule Specifications | Teva North America / 14, 370 units | Class III | Terminated |
| D-1475-2016 | 05-17-2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N) | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. | Clinique International / 1,771,244 bottles for all shades | Class III | Terminated |
| D-1012-2016 | 05-17-2016 | TESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1478-2016 | 05-17-2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48241-1, Shade 06 (D-G) | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. | Clinique International / 1,771,244 bottles for all shades | Class III | Terminated |
| D-1026-2016 | 05-17-2016 | CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 916 total | Class II | Terminated |
| D-0991-2016 | 05-17-2016 | Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1007-2016 | 05-17-2016 | QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0984-2016 | 05-17-2016 | ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1017-2016 | 05-17-2016 | TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1022-2016 | 05-17-2016 | VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1005-2016 | 05-17-2016 | PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1000-2016 | 05-17-2016 | METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1024-2016 | 05-17-2016 | VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0981-2016 | 05-17-2016 | ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0979-2016 | 05-17-2016 | ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0978-2016 | 05-17-2016 | 17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 units (total all products) | Class II | Terminated |
| D-0985-2016 | 05-17-2016 | GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1023-2016 | 05-17-2016 | VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1002-2016 | 05-17-2016 | METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1010-2016 | 05-17-2016 | SUPER TRI-MIX #4, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1014-2016 | 05-17-2016 | TESTOSTERONE CYPIONATE 175MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1021-2016 | 05-17-2016 | TRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0996-2016 | 05-17-2016 | M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1028-2016 | 05-17-2016 | ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 916 total units | Class II | Terminated |
| D-1008-2016 | 05-17-2016 | QUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0990-2016 | 05-17-2016 | HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0995-2016 | 05-17-2016 | M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1004-2016 | 05-17-2016 | PHENYLEPHERINE 0.5%, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0999-2016 | 05-17-2016 | METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1016-2016 | 05-17-2016 | TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1027-2016 | 05-17-2016 | ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 916 total units | Class II | Terminated |
| D-0992-2016 | 05-17-2016 | LEVOCARNITINE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1025-2016 | 05-17-2016 | QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1001-2016 | 05-17-2016 | METHYLCOBALAMIN 5MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0997-2016 | 05-17-2016 | MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1011-2016 | 05-17-2016 | TESTOSTERONE CYPIONATE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1474-2016 | 05-17-2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47477-5, Shade 02 (VF-N) | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. | Clinique International / 1,771,244 bottles for all shades | Class III | Terminated |
| D-1009-2016 | 05-17-2016 | SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1019-2016 | 05-17-2016 | TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0998-2016 | 05-17-2016 | M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / N/A | Class II | Terminated |
| D-1006-2016 | 05-17-2016 | QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0980-2016 | 05-17-2016 | ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (All Products) | Class II | Terminated |
| D-1003-2016 | 05-17-2016 | MYERS' COCKTAIL, packaged in 37 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0988-2016 | 05-17-2016 | 1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0989-2016 | 05-17-2016 | 1-HCG 2000 IU/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1015-2016 | 05-17-2016 | TESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0983-2016 | 05-17-2016 | ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0949-2016 | 05-17-2016 | Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12 | Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability | Akorn, Inc. / 57,920 bottles | Class II | Terminated |
| D-0986-2016 | 05-17-2016 | GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0994-2016 | 05-17-2016 | M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0993-2016 | 05-17-2016 | L-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0987-2016 | 05-17-2016 | GLUTATHIONE 200MG/ML, packaged in 5mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1013-2016 | 05-17-2016 | TESTOSTERONE CYPIONATE 150MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-0982-2016 | 05-17-2016 | ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1018-2016 | 05-17-2016 | TRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1020-2016 | 05-17-2016 | TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility. | Well Care Compounding Pharmacy / 869 Units (Total All Products) | Class II | Terminated |
| D-1476-2016 | 05-17-2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47479-9, Shade 04 (M-N) | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. | Clinique International / 1,771,244 bottles for all shades | Class III | Terminated |
| D-1473-2016 | 05-17-2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47476-8, Shade 01 (VF-N) | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. | Clinique International / 1,771,244 bottles for all shades | Class III | Terminated |
| D-1477-2016 | 05-17-2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48240-4, Shade 05 (D-G) | Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. | Clinique International / 1,771,244 bottles for all shades | Class III | Terminated |
| D-0976-2016 | 05-16-2016 | Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-836-11, Service Code 2K5836. | Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride. | Pharmedium Services, LLC / 240 bags | Class II | Terminated |
| D-1048-2016 | 05-16-2016 | VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30 | Defective delivery system: Softgel capsules are leaking. | Virtus Pharmaceuticals, Llc / 1,586 bottles | Class III | Terminated |
| D-1212-2016 | 05-13-2016 | MANGANESE CHL 0.1MG/ML PF, 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1217-2016 | 05-13-2016 | METHYL B12 1000MCG/ML IN NACL 0.9% (PF), 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 2000 mL in Vials | Class II | Terminated |
| D-1226-2016 | 05-13-2016 | MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 21000 mL in Vials | Class II | Terminated |
| D-1197-2016 | 05-13-2016 | L-CARNITINE 500MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 500 mL in Vials | Class II | Terminated |
| D-1198-2016 | 05-13-2016 | L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 5000 mL in Vials | Class II | Terminated |
| D-1224-2016 | 05-13-2016 | M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 500 mL in Vials | Class II | Terminated |
| D-1232-2016 | 05-13-2016 | PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1500 mL in Vials | Class II | Terminated |
| D-1229-2016 | 05-13-2016 | NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 358000 mL in Vials | Class II | Terminated |
| D-1187-2016 | 05-13-2016 | GERMANIUM SESO 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 49 mL in Vials | Class II | Terminated |
| D-1249-2016 | 05-13-2016 | TRYPTOPHAN 10MG/ML (PF), In a) 10ML Vials and b) 50ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 2000 mL in Vials | Class II | Terminated |
| D-1186-2106 | 05-13-2016 | GABA 50MG/ML (PF), 50ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 110 mL in Vials | Class II | Terminated |
| D-1243-2016 | 05-13-2016 | TESTOSTERONE CYP 20 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials and b) 3ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 20 mL in Vials | Class II | Terminated |
| D-1225-2016 | 05-13-2016 | M.I.C 25/50/50 W/METHYL B12 1MG/PYRIDOXAL 50MG/ML (PF), 1ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 2000 mL in Vials | Class II | Terminated |
| D-1239-2016 | 05-13-2016 | TAURINE 50 MG/ML (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 5500 mL in Vials | Class II | Terminated |
| D-1196-2016 | 05-13-2016 | L-CARNITINE 250MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 2250 mL in Vials | Class II | Terminated |
| D-1170-2016 | 05-13-2016 | B-COMPLEX WITHOUT B12 (PF) IN NACL 0.9%, B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 4000 mL in Vials | Class II | Terminated |
| D-1235-2016 | 05-13-2016 | PYRIDOXINE HCL 100MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 2000 mL in Vials | Class II | Terminated |
| D-1207-2016 | 05-13-2016 | LIPO-INJECTION W/METHYL B12 500 MCG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 4000 mL in Vials | Class II | Terminated |
| D-1213-2016 | 05-13-2016 | MANGANESE SO4 0.1MG/ML (PF), In a) 2MLVials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 3000 mL in Vials | Class II | Terminated |
| D-1185-2016 | 05-13-2016 | FOLIC ACID 10MG/ML W/PRES. (METHYLPARABEN 0.05%, PROPYLPARABEN 0.025% IN NACL, 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 500 mL in Vials | Class II | Terminated |
| D-1242-2016 | 05-13-2016 | TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and e) 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 8000 mL in Vials | Class II | Terminated |
| D-1174-2016 | 05-13-2016 | B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, c) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 62 mL in Vials | Class II | Terminated |
| D-1233-2016 | 05-13-2016 | PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 60 mL in Vials | Class II | Terminated |
| D-1205-2016 | 05-13-2016 | LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50 MG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE 30MG/ML, In a) 3ML Vials and b) 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 65 mL in Vials | Class II | Terminated |
| D-1210-2016 | 05-13-2016 | LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 14000 mL in Vials | Class II | Terminated |
| D-1241-2016 | 05-13-2016 | TESTOSTERONE CYP 100 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, and d) 5 ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 500 mL in Vials | Class II | Terminated |
| D-1189-2016 | 05-13-2016 | HYDROGEN PEROXIDE 3% (PF), 5ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 1000 mL in Vials | Class II | Terminated |
| D-1218-2016 | 05-13-2016 | METHYL B12 5MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 600 mL in Vials | Class II | Terminated |
| D-1221-2016 | 05-13-2016 | M.I.C./B-COMPLEX (PF) B1-50MG;B2-5-PO4-5MG;B3-50MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-5MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 3000 mL in Vials | Class II | Terminated |
| D-1211-216 | 05-13-2016 | MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Medaus, Inc. / 5000 mL in Vials | Class II | Terminated |
