Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0727-2017 | 04-18-2017 | HYDROXO-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, packaged in a 5 mL and 30 mL Glass/ Multiple Dose vials, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 27 vials total (25/5 mL vials and 2/30mL vials) | Class II | Terminated |
| D-0726-2017 | 04-18-2017 | HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0735-2017 | 04-18-2017 | TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0715-2017 | 04-18-2017 | DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 10 mL total | Class II | Terminated |
| D-0761-2017 | 04-18-2017 | CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0739-2017 | 04-18-2017 | TRI MIX 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ, Injection, 11.8mcg/17.6mg/0.59mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0783-2017 | 04-18-2017 | TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 6 vials total (5/5mL vials and 1/10mL vial) | Class II | Terminated |
| D-0758-2017 | 04-18-2017 | ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0710-2017 | 04-18-2017 | 5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial) | Class II | Terminated |
| D-0695-2017 | 04-17-2017 | Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5. | Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container. | Fagron, Inc / | Class III | Terminated |
| D-0377-2019 | 04-17-2017 | EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01 | CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. | Syntho Pharmaceuticals, Inc. / 5,000 bottles | Class II | Terminated |
| D-0919-2017 | 04-17-2017 | ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327 | cGMP Deviations; lack of quality assurance. | American Pharmaceutical Ingredients LLC / 1g=1 bottle; 5g=4 bottle; 25g=3 bottles | Class II | Terminated |
| D-0378-2019 | 04-17-2017 | EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-010-01 | CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. | Syntho Pharmaceuticals, Inc. / 5,000 bottles | Class II | Terminated |
| D-0694-2017 | 04-17-2017 | Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072, UPC 3-59726-72025-0; (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24, UPC 0-75450-12369-2; (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24, UPC 3-59726-72025-0; (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24, UPC 8-83967-39839-3. | Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point. | P & L Development, LLC / 369,012 cartons | Class III | Terminated |
| D-0881-2017 | 04-13-2017 | Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435. | CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection. | Spectrum Laboratory Products, Inc. / 48 containers | Class II | Terminated |
| D-0882-2017 | 04-13-2017 | Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229. | CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection. | Spectrum Laboratory Products, Inc. / 1 container | Class II | Terminated |
| D-0864-2017 | 04-13-2017 | Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottle, Manufactured for: Hyland's, Inc., Los Angesles, CA 90061, NDC 54973-3197-1, UPC 3 54973 31971 4. | Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels. | Standard Homeopathic Company / 692,115 bottles | Class I | Terminated |
| D-0863-2017 | 04-13-2017 | Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bottles (NDC 54973-3127-1) (UPCs 3 54973 31271 5, 3 54973 31371 2, 3 54973 31481 8); and 250-count bottles (NDC 54973-3127-2) (UPCs 3 54973 31272 2, 3 54973 31521 1), Manufactured for: Hyland's, Inc., Los Angeles, CA 90061. | Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels. | Standard Homeopathic Company / 10,263,585 bottles | Class I | Terminated |
| D-0787-2017 | 04-07-2017 | Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, Inc. Buena. New Jersey 08310 NDC 52565-030-15 | Superpotent Drug | Teligent, Inc. / 3600 tubes | Class III | Terminated |
| D-0686-2017 | 04-06-2017 | Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 2,156 vials | Class II | Terminated |
| D-0681-2017 | 04-06-2017 | Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 4,001 vials | Class II | Terminated |
| D-1166-2017 | 04-06-2017 | Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-605-52 | Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product. | PharMedium Services, Llc / 295 bags | Class II | Terminated |
| D-0685-2017 | 04-06-2017 | Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 851 vials | Class II | Terminated |
| D-0791-2017 | 04-06-2017 | Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estriol USP Micronized, For prescription compounding, packaged in a 100 G bottle (NDC 52372-9292-01), Rx only, Distributed by FREEDOM, 801 W. New Orleans St. Broken Arrow, OK 74011 | cGMP Deviations: lack of quality assurance at the API manufacturer. | Fagron, Inc / 15283 grams | Class II | Terminated |
| D-0792-2017 | 04-06-2017 | Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 52372-9494-02), Rx only, Distributed by FREEDOM 801 W. New Orleans St. Broken Arrow, OK 74011 Tel. (877) 839-8547 | cGMP Deviations: lack of quality assurance at the API manufacturer. | Fagron, Inc / 1313 grams | Class II | Terminated |
| D-0683-2017 | 04-06-2017 | Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 2,335 vials | Class II | Terminated |
| D-1165-2017 | 04-06-2017 | Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52. | Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product. | PharMedium Services, Llc / 590 bags | Class II | Terminated |
| D-0682-2017 | 04-06-2017 | Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 2,352 vials | Class II | Terminated |
| D-0687-2017 | 04-06-2017 | Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 5,165 bottles | Class II | Terminated |
| D-0684-2017 | 04-06-2017 | Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 1,951 vials | Class II | Terminated |
| D-0651-2017 | 04-04-2017 | Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by Cipla Limited Kurkumbh, Maharashtra, India, Manufactured for West-Ward, Pharmaceuticals, Corp., Eatontown, NJ -- NDC 0054-0338-19 | Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print. | West-Ward Columbus, Inc. / 100 bottles | Class III | Terminated |
| D-0665-2017 | 04-03-2017 | ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0869 | cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection | Medisca, Inc. / N/A | Class II | Terminated |
| D-0664-2017 | 04-03-2017 | ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891 | cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection | Medisca, Inc. / N/A | Class II | Terminated |
| D-0666-2017 | 04-03-2017 | ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261 | cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection | Medisca, Inc. / N/A | Class II | Terminated |
| D-0865-2017 | 04-03-2017 | Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784190442214, 2) 4x15 mL and one 5 mL bonus bottles, USPC Code 069886941746, Distributed by Cell Distributors, Union, NJ | Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel. | Cell Distributors / 2,634 bottles (58 bottles/5mL & 2576 bottles/15 mL) | Class II | Terminated |
| D-0663-2017 | 04-03-2017 | ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732 | cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection | Medisca, Inc. / N/A | Class II | Terminated |
| D-1051-2017 | 03-30-2017 | Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500041085 | Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. | Bayer HealthCare Pharmaceuticals, Inc. / 56,064 36-count cartons | Class II | Terminated |
| D-1050-2017 | 03-30-2017 | Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048 | Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. | Bayer HealthCare Pharmaceuticals, Inc. / 24,672 24-count cartons | Class II | Terminated |
| D-1044-2017 | 03-30-2017 | Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194 | Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. | Bayer HealthCare Pharmaceuticals, Inc. / 1,067,520 12-count cartons | Class II | Terminated |
| D-0677-2017 | 03-28-2017 | hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12, Stabilizers/Excipients, Not For Medical Use, Must Be Refrigerated, Distributed by HCG Body Shaper, St. Peters, MO | Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug | Gary Wood / 1305-1400 bottles | Class II | Terminated |
| D-0703-2017 | 03-28-2017 | PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87 | Failed Stability Specifications | Teva Pharmaceuticals USA / 49,089 bottles | Class III | Terminated |
| D-0676-2017 | 03-28-2017 | Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532 Package NDCs: 51672-1272-1; 51672-1272-2; 51672-1272-3; 51672-1263-1; 51672-1263-2; 51672-1263-3 | Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability | Taro Pharmaceuticals U.S.A., Inc. / 278,304 tubes | Class II | Terminated |
| D-0867-2017 | 03-28-2017 | LaBri's Body Health Atomic, 60 capsules | Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine. | Envy Me / unknown | Class I | Terminated |
| D-0654-2017 | 03-24-2017 | Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-001-01) (44132-001-06) | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0656-2017 | 03-24-2017 | Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06 | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0655-2017 | 03-24-2017 | Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0657-2017 | 03-24-2017 | Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06) | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0660-2017 | 03-24-2017 | Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-012-01), | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0658-2017 | 03-24-2017 | Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06) | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0659-2017 | 03-24-2017 | Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-002-05) | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0699-2017 | 03-22-2017 | Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18. | Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). | Sun Pharmaceutical Industries, Inc. / 60 bottles | Class III | Terminated |
| D-0678-2017 | 03-22-2017 | Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15 | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corp. / N/A | Class III | Terminated |
| D-0702-2017 | 03-22-2017 | Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India. | Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). | Sun Pharmaceutical Industries, Inc. / 14,784 bottles | Class III | Terminated |
| D-0701-2017 | 03-22-2017 | Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India, NDC 62756-551-18. | Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). | Sun Pharmaceutical Industries, Inc. / 38,316 bottles | Class III | Terminated |
| D-0626-2017 | 03-22-2017 | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20. Package NDCs: 0173-0682-20; 0173-0682-24 | Defective Delivery System: Elevated number of units with out of specification results for leak rate. | GlaxoSmithKline, LLC / 593,088 inhalers | Class II | Ongoing |
| D-0679-2017 | 03-22-2017 | Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15 Package NDCs: 61314-203-15; 61314-204-15; 61314-206-15 | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corp. / N/A | Class III | Terminated |
| D-0700-2017 | 03-22-2017 | Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India. | Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). | Sun Pharmaceutical Industries, Inc. / 6,138 bottles | Class III | Terminated |
| D-0622-2017 | 03-21-2017 | Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20 Package NDCs: 51079-208-01; 51079-208-20; 51079-209-01; 51079-209-20; 51079-210-01; 51079-210-20; 51079-211-01; 51079-211-03 | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 1,527 cartons | Class II | Terminated |
| D-0672-2017 | 03-20-2017 | CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04 | Discoloration. | Valeant Pharmaceuticals North America LLC / 38,767 units | Class III | Terminated |
| D-0619-2017 | 03-20-2017 | Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-3950-77; 0378-3950-05; 0378-3950-09; 0378-3950-07; 0378-3951-77; 0378-3951-05; 0378-3951-09; 0378-3951-07; 0378-3952-77; 0378-3952-05; 0378-3952-09; 0378-3952-07; 0378-3953-77; 0378-3953-05; 0378-3953-09; 0378-3953-07 | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Mylan Pharmaceuticals Inc. / 299,112 bottles | Class II | Terminated |
| D-0618-2017 | 03-20-2017 | Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-3950-77; 0378-3950-05; 0378-3950-09; 0378-3950-07; 0378-3951-77; 0378-3951-05; 0378-3951-09; 0378-3951-07; 0378-3952-77; 0378-3952-05; 0378-3952-09; 0378-3952-07; 0378-3953-77; 0378-3953-05; 0378-3953-09; 0378-3953-07 | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Mylan Pharmaceuticals Inc. / 1,233,107 bottles | Class II | Terminated |
| D-0621-2017 | 03-20-2017 | Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-3950-77; 0378-3950-05; 0378-3950-09; 0378-3950-07; 0378-3951-77; 0378-3951-05; 0378-3951-09; 0378-3951-07; 0378-3952-77; 0378-3952-05; 0378-3952-09; 0378-3952-07; 0378-3953-77; 0378-3953-05; 0378-3953-09; 0378-3953-07 | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Mylan Pharmaceuticals Inc. / 452,269 bottles | Class II | Terminated |
| D-0620-2017 | 03-20-2017 | Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-3950-77; 0378-3950-05; 0378-3950-09; 0378-3950-07; 0378-3951-77; 0378-3951-05; 0378-3951-09; 0378-3951-07; 0378-3952-77; 0378-3952-05; 0378-3952-09; 0378-3952-07; 0378-3953-77; 0378-3953-05; 0378-3953-09; 0378-3953-07 | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Mylan Pharmaceuticals Inc. / 444,201 bottles | Class II | Terminated |
| D-0673-2017 | 03-20-2017 | CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA, Product SKU 301876103018, NDC 0187-6103-01 | Discoloration. | Valeant Pharmaceuticals North America LLC / 5,647 units | Class III | Terminated |
| D-0636-2017 | 03-20-2017 | Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080. Package NDCs: 0713-0638-15; 0713-0638-31; 0713-0638-18 | Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert. | G & W Laboratories, Inc. / 230,700 tubes | Class III | Terminated |
| D-0625-2017 | 03-17-2017 | Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01 Package NDCs: 47783-101-01 | Presence of Particulate Matter: Glass | Shire / 3, 536 cartons (3 vials per carton) | Class II | Terminated |
| D-0790-2017 | 03-17-2017 | Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3 Package NDCs: 51672-1253-1; 51672-1253-2; 51672-1253-3; 51672-1253-4; 51672-1254-1; 51672-1254-2; 51672-1254-3; 51672-1279-1; 51672-1279-2; 51672-1279-3; 51672-1264-1; 51672-1264-2; 51672-1264-3 | Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate. | Taro Pharmaceuticals U.S.A., Inc. / 7,776 tubes | Class III | Terminated |
| D-0661-2017 | 03-17-2017 | LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12 | Lack of assurance of sterility: product was found to be empty, under-filled, or leaking. | Akorn, Inc. / 107,940 bottles | Class II | Terminated |
| D-0647-2017 | 03-16-2017 | Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05 | Subpotent Drug | Fresenius Kabi USA, LLC / 118,224 vials | Class III | Terminated |
| D-0667-2017 | 03-16-2017 | Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08. Package NDCs: 0023-3205-02; 0023-3205-03; 0023-3205-05; 0023-3205-08 | Failed Impurities/Degradation Specifications | Allergan Sales, LLC / 56,878 bottles | Class III | Terminated |
| D-0611-2017 | 03-15-2017 | Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun Pharma Ind. Inc., NJ 08512, Manufactured by Sun Pharma Ind. Ltd. India, NDC 62756-015-40 Package NDCs: 62756-017-40; 62756-015-40; 62756-016-40 | Presence of Particulate Matter | Sun Pharmaceutical Industries, Inc. / 83,188 single does vials | Class II | Terminated |
| D-0617-2017 | 03-15-2017 | Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ | Failed Dissolution Specifications; 9 month long term stability | Zydus Pharmaceuticals USA Inc / 32628 bottles | Class II | Terminated |
| D-0648-2017 | 03-13-2017 | Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CA. 94080, NDC 50242-717-01,UPC 3 50242-717-01. Package NDCs: 50242-717-01 | Superpotent Drug: An oversized tablet was found in a bottle. | Genentech Inc. / 748 bottles | Class II | Terminated |
| D-0696-2017 | 03-13-2017 | Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16 | Failed Dissolution Specifications | Akorn Inc / 55,968 bottles | Class II | Terminated |
| D-0690-2017 | 03-12-2017 | EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company. Package NDCs: 49502-500-01; 49502-500-02; 49502-500-92; 49502-501-01; 49502-501-02; 49502-501-92 | Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication | Meridian Medical Technologies a Pfizer Company / 373,960 2-paks (U.S.) ; 331,738 auto-injectors (O.U.S.) | Class I | Ongoing |
| D-0691-2017 | 03-12-2017 | EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS: Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company. Package NDCs: 49502-500-01; 49502-500-02; 49502-500-92; 49502-501-01; 49502-501-02; 49502-501-92 | Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication | Meridian Medical Technologies a Pfizer Company / 92,544 2-pak (U.S.); 198,579 syringes (O.U.S.) | Class I | Ongoing |
| D-0613-2017 | 03-10-2017 | Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24 | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product. | Claris Lifesciences Inc / 18,360 units (765 cartons x 24 bags) | Class II | Terminated |
| D-0615-2017 | 03-10-2017 | Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24 Package NDCs: 36000-045-01; 36000-046-24; 36000-047-24; 36000-048-24 | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product. | Claris Lifesciences Inc / 24,456 units (1019 cartons x 24 bags) | Class II | Terminated |
| D-0616-2017 | 03-10-2017 | Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24 | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product. | Claris Lifesciences Inc / 72072 units | Class II | Terminated |
| D-0614-2017 | 03-10-2017 | Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06 | Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product. | Claris Lifesciences Inc / 18,096 units (3016 cartons x 6 bags) | Class II | Terminated |
| D-0518-2017 | 03-08-2017 | Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1 | CGMP Deviations | Isomeric Pharmacy Solution, LLC / 6,999 single-use vials | Class II | Terminated |
| D-0668-2017 | 03-08-2017 | hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc. Package NDCs: 63323-614-00; 63323-614-01 | Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation. | Mckesson Medical Surgical / 98 vials | Class II | Terminated |
| D-0633-2017 | 03-07-2017 | Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401 | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0629-2017 | 03-07-2017 | Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05 | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0627-2017 | 03-07-2017 | Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01. | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0630-2017 | 03-07-2017 | Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01. | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0634-2017 | 03-07-2017 | Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501 | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0631-2017 | 03-07-2017 | Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01. | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0632-2017 | 03-07-2017 | Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 50419-70305 | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0635-2017 | 03-07-2017 | Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601 | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0628-2017 | 03-07-2017 | Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05 | Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib | Alvogen, Inc / N/A | Class III | Terminated |
| D-0563-2018 | 03-07-2017 | Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0570-2018 | 03-07-2017 | LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0557-2018 | 03-07-2017 | HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class II | Terminated |
| D-0556-2018 | 03-07-2017 | GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0565-2018 | 03-07-2017 | MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class II | Terminated |
| D-0560-2018 | 03-07-2017 | Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0552-2018 | 03-07-2017 | Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class II | Terminated |
| D-0569-2018 | 03-07-2017 | DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
| D-0562-2018 | 03-07-2017 | ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. | A&H Focal Inc. / unknown | Class I | Terminated |
