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-824-2013 | 05-16-2013 | West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724 | Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets. | West-Ward Pharmaceutical Corp. / 14,503 bottles | Class II | Terminated |
| D-825-2013 | 05-16-2013 | West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724 | Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol. | West-Ward Pharmaceutical Corp. / 7,324 bottles | Class II | Terminated |
| D-501-2013 | 05-16-2013 | Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 Package NDCs: 0409-3213-11; 0409-3213-12 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. | Hospira Inc. / 95,700 vials | Class II | Terminated |
| D-593-2013 | 05-15-2013 | Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. | Pentec Health / 1 Bag | Class II | Terminated |
| D-592-2013 | 05-15-2013 | Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. | Pentec Health / 4 Bags | Class II | Terminated |
| D-588-2013 | 05-15-2013 | Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. | Pentec Health / 59 Bags | Class II | Terminated |
| D-585-2013 | 05-15-2013 | IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. | Pentec Health / 3 Bags | Class II | Terminated |
| D-595-2013 | 05-15-2013 | Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. | Pentec Health / 3 Bags | Class II | Terminated |
| D-829-2013 | 05-15-2013 | Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA | Failed Impurity/Degradation Specification; "Related Compound C" | Actavis South Atlantic LLC / A total of 133,968 bottles (units) | Class II | Terminated |
| D-590-2013 | 05-15-2013 | Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. | Pentec Health / 1 Bag | Class II | Terminated |
| D-582-2013 | 05-15-2013 | Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. | Pentec Health / 3 units | Class II | Terminated |
| D-583-2013 | 05-15-2013 | Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. | Pentec Health / 5 Bags | Class II | Terminated |
| D-584-2013 | 05-15-2013 | Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions | Pentec Health / 1 Bag | Class II | Terminated |
| D-581-2013 | 05-15-2013 | Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. | Pentec Health / 1 Bag | Class II | Terminated |
| D-591-2013 | 05-15-2013 | Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. | Pentec Health / 1 Bag | Class II | Terminated |
| D-587-2013 | 05-15-2013 | Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. | Pentec Health / 25 Bags | Class II | Terminated |
| D-594-2013 | 05-15-2013 | Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. | Pentec Health / 8 Bags | Class II | Terminated |
| D-589-2013 | 05-15-2013 | Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions | Pentec Health / 38 Bags | Class II | Terminated |
| D-586-2013 | 05-15-2013 | Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132 | Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. | Pentec Health / 9 Bags | Class II | Terminated |
| D-452-2013 | 05-15-2013 | Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03. | Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 1,621 boxes | Class III | Terminated |
| D-740-2014 | 05-15-2013 | Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2084-24. | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Novartis Consumer Health / 38,856/24-caplet package | Class III | Terminated |
| D-739-2014 | 05-15-2013 | Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24. | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Novartis Consumer Health / 32,256/24-caplet packages | Class III | Terminated |
| D-743-2014 | 05-15-2013 | Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24). Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622. | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Novartis Consumer Health / 3,768/8-caplet packages and 300,580/24-caplet packages | Class III | Terminated |
| D-742-2014 | 05-15-2013 | Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622. | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing | Novartis Consumer Health / 98,024/8-caplet packages and 557,548/24-caplet packages | Class III | Terminated |
| D-1067-2014 | 05-15-2013 | HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433. | Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic) | Health & Beyond / 46 bottles | Class II | Terminated |
| D-744-2014 | 05-15-2013 | Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02. | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing | Novartis Consumer Health / 2,978,000/2-caplet packages | Class III | Terminated |
| D-741-2014 | 05-15-2013 | Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2081-24 | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Novartis Consumer Health / 167,712/24-caplet packages | Class III | Terminated |
| D-738-2014 | 05-15-2013 | Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2082-32. | Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. | Novartis Consumer Health / 104,328/32-caplet packages | Class III | Terminated |
| D-0252-2015 | 05-13-2013 | Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX | Non-Sterility; contract laboratory identified Staphylococcus warneri in the product | Abrams Royal Pharmacy / 21 vials | Class I | Terminated |
| D-838-2013 | 05-13-2013 | Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10 | Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized. | Zydus Pharmaceuticals USA Inc / 960 Bottles | Class I | Terminated |
| D-691-2013 | 05-13-2013 | Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10 Package NDCs: 0143-9689-01; 0143-9689-10; 0143-9633-01; 0143-9633-10; 0143-9634-01; 0143-9634-10 | Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D) | West-ward Pharmaceutical Corp. / Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials | Class III | Terminated |
| D-835-2013 | 05-10-2013 | Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0 | Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution. | Apotex Corp. / 52,398 vials | Class I | Terminated |
| D-1055-2014 | 05-08-2013 | Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML | Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits. | Fusion Pharmaceuticals, LLC / 1,200 kits | Class II | Terminated |
| D-610-2013 | 05-07-2013 | Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04. | Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. | Hill Dermaceuticals, Inc. / 8,808 bottles | Class III | Terminated |
| D-833-2013 | 05-06-2013 | Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2). | Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug. | Chang Kwung Products / 3,720 capsules total | Class I | Terminated |
| D-834-2013 | 05-06-2013 | Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8). | Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug. | Chang Kwung Products / 3,720 capsules total | Class I | Terminated |
| D-620-2013 | 05-03-2013 | Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2 | Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine | Kareway Product Inc / 24,048 cartons | Class II | Terminated |
| D-554-2013 | 05-02-2013 | Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 2 vials of 100mL | Class II | Terminated |
| D-560-2013 | 05-02-2013 | Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 4 vials of 10mL each | Class II | Terminated |
| D-568-2013 | 05-02-2013 | Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 1 vial of 40mL | Class II | Terminated |
| D-556-2013 | 05-02-2013 | Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 vials of 10mL | Class II | Terminated |
| D-566-2013 | 05-02-2013 | MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 14 vials of 30mL each | Class II | Terminated |
| D-555-2013 | 05-02-2013 | Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 41 vials of 2mL | Class II | Terminated |
| D-549-2013 | 05-02-2013 | Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | THE COMPOUNDING SHOP, INC. / 80 vials of 4mL each | Class II | Terminated |
| D-552-2013 | 05-02-2013 | Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 3 vials of 45mL | Class II | Terminated |
| D-570-2013 | 05-02-2013 | Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 5 vials of 50mL | Class II | Terminated |
| D-561-2013 | 05-02-2013 | Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 44 vials of 50mL each | Class II | Terminated |
| D-557-2013 | 05-02-2013 | Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 43 vials of 250mL each | Class II | Terminated |
| D-569-2013 | 05-02-2013 | Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 1 vial of 40ml | Class II | Terminated |
| D-558-2013 | 05-02-2013 | Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 7 vials of 50mL each | Class II | Terminated |
| D-567-2013 | 05-02-2013 | Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 1 vial of 6mL, 19 vials of 10mL each and 1 vial of 40mL | Class II | Terminated |
| D-571-2013 | 05-02-2013 | MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 10 vials of 30 mL each | Class II | Terminated |
| D-686-2013 | 05-02-2013 | Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA. Package NDCs: 0409-1207-13; 0409-1207-03 | Presence of Particulate Matter: visible particles were identified floating in the primary container. | Hospira Inc. / 168,300 vals | Class II | Terminated |
| D-565-2013 | 05-02-2013 | Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 32 vials of 50mL | Class II | Terminated |
| D-563-2013 | 05-02-2013 | Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 78 vials of 500ml and 92 vials of 100mL | Class II | Terminated |
| D-559-2013 | 05-02-2013 | Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 55 vials of 100mL | Class II | Terminated |
| D-553-2013 | 05-02-2013 | Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 20 vials of 5mL | Class II | Terminated |
| D-564-2013 | 05-02-2013 | B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 56 vials of 50mL | Class II | Terminated |
| D-572-2013 | 05-02-2013 | Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 4 vials of 5mL and 22 vials of 10mL | Class II | Terminated |
| D-562-2013 | 05-02-2013 | Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | THE COMPOUNDING SHOP, INC. / 2 vials of 250mL and 26 vials of 100mL | Class II | Terminated |
| D-550-2013 | 05-02-2013 | Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | THE COMPOUNDING SHOP, INC. / 1 vial of 22mL | Class II | Terminated |
| D-548-2013 | 05-02-2013 | Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | THE COMPOUNDING SHOP, INC. / 19 vials of 10ml | Class II | Terminated |
| D-551-2013 | 05-02-2013 | Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | THE COMPOUNDING SHOP, INC. / 1 vial of 20mL and 1 vial of 40mL | Class II | Terminated |
| D-929-2013 | 05-01-2013 | SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ | Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug | Beamonstar Products / 673,851 capsules | Class I | Terminated |
| D-930-2013 | 05-01-2013 | Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ | Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug | Beamonstar Products / 145,632 capsules | Class I | Terminated |
| D-916-2013 | 05-01-2013 | CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl Peroxide 5%) NDC 562032-113). Product under recall is the Pore Therapy (Salicylic Acid 2%), NDC 62032-110. | cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy | Medicis Pharmaceutical Corp / 2491 Kits; Expanded 8/29/2013 to include an additional 907 units. | Class II | Terminated |
| D-1223-2014 | 04-30-2013 | Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary Supplement. UPC 893490820087 (product numbers may possibly vary for same product identification and same product packaging), distributed by Vicerex.com. | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs. | American Lifestyle.Com / 13 boxes distributed domestically & 50 boxes distributed internationally to consumers | Class I | Terminated |
| D-423-2013 | 04-30-2013 | Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 60793-852-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Subpotent Drug: The products were below specification for potency at the expiry stability point. | King Legacy, a wholly owned subsidiary of Pfizer / 194,142 bottles | Class II | Terminated |
| D-431-2013 | 04-30-2013 | Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles (NDC 60793-860-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Subpotent Drug: The products were below specification for potency at the expiry stability point. | King Legacy, a wholly owned subsidiary of Pfizer / 33,227 bottles | Class II | Terminated |
| D-421-2013 | 04-30-2013 | Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 60793-850-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Subpotent Drug: The products were below specification for potency at the expiry stability point. | King Legacy, a wholly owned subsidiary of Pfizer / 51,591 bottles | Class II | Terminated |
| D-424-2013 | 04-30-2013 | Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 60793-853-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Subpotent Drug: The products were below specification for potency at the expiry stability point. | King Legacy, a wholly owned subsidiary of Pfizer / 112,914 bottles | Class II | Terminated |
| D-429-2013 | 04-30-2013 | Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC 60793-858-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Subpotent Drug: The products were below specification for potency at the expiry stability point. | King Legacy, a wholly owned subsidiary of Pfizer / 56,405 bottles | Class II | Terminated |
| D-425-2013 | 04-30-2013 | Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Subpotent Drug: The products were below specification for potency at the expiry stability point. | King Legacy, a wholly owned subsidiary of Pfizer / 195,201 bottles | Class II | Terminated |
| D-427-2013 | 04-30-2013 | Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles (NDC 60793-856-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Subpotent Drug: The products were below specification for potency at the expiry stability point. | King Legacy, a wholly owned subsidiary of Pfizer / 103,796 bottles | Class II | Terminated |
| D-422-2013 | 04-30-2013 | Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 60793-851-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Subpotent Drug: The products were below specification for potency at the expiry stability point. | King Legacy, a wholly owned subsidiary of Pfizer / 195,699 bottles | Class II | Terminated |
| D-430-2013 | 04-30-2013 | Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles (NDC 60793-859-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Subpotent Drug: The products were below specification for potency at the expiry stability point. | King Legacy, a wholly owned subsidiary of Pfizer / 51,438 bottles | Class II | Terminated |
| D-603-2013 | 04-30-2013 | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16 | Subpotent; 24 month stability test station | Hi-Tech Pharmacal Co., Inc. / lot 608917: 7764 bottles; lot 608204: 7476 bottles | Class III | Terminated |
| D-1224-2014 | 04-30-2013 | Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on the front, the back side of the box contains mostly foreign character. Within the box there are four (4) capsules individually wrapped in black and red plastic with white lettering. UPC 4026666142546 (product numbers may possibly vary for same product identification and same product packaging). | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs. | American Lifestyle.Com / 3 boxes distributed domestically & 4 boxes distributed internationally to consumers. | Class I | Terminated |
| D-428-2013 | 04-30-2013 | Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Subpotent Drug: The products were below specification for potency at the expiry stability point. | King Legacy, a wholly owned subsidiary of Pfizer / 77,272 bottles | Class II | Terminated |
| D-426-2013 | 04-30-2013 | Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC 60793-855-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Subpotent Drug: The products were below specification for potency at the expiry stability point. | King Legacy, a wholly owned subsidiary of Pfizer / 107,236 bottles | Class II | Terminated |
| D-502-2013 | 04-30-2013 | DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32 Package NDCs: 0409-2347-31; 0409-2347-32; 0409-2346-31; 0409-2346-32; 0409-3724-11; 0409-3724-32; 0409-0025-01; 0409-0025-10; 0409-0151-01; 0409-0151-10; 0409-1100-01; 0409-1100-10 | Lack of Assurance of Sterility: Confirmed report of leaking in the primary container. | Hospira Inc. / 44,748 bags | Class II | Terminated |
| D-598-2013 | 04-26-2013 | Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL) Package NDCs: 0093-2263-01; 0093-2264-01; 0093-4160-76; 0093-4160-78; 0093-4160-73; 0093-4155-79; 0093-4155-73; 0093-4155-80; 0093-4161-76; 0093-4161-78; 0093-4161-73; 0093-2267-01; 0093-2268-01; 0093-3107-01; 0093-3107-05; 0093-3109-53; 0093-3109-05 | Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles. | Teva Pharmaceuticals USA, Inc. / 758,554 bottles | Class III | Terminated |
| D-1056-2014 | 04-24-2013 | Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393. | Marketed without an Approved NDA/ANDA. | Insight Instruments, Inc. / 316,464 kits | Class II | Terminated |
| D-319-2013 | 04-22-2013 | Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. Packaged by: Legacy Pharmaceutical Packaging, LLC, Earth City, MO. NDC 68645-445-70. | Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg. | Legacy Pharmaceutical Packaging LLC / 484,236 cartons | Class II | Terminated |
| D-475-2013 | 04-22-2013 | Folic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-465-2013 | 04-22-2013 | Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-476-2013 | 04-22-2013 | HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 3 | Class II | Terminated |
| D-478-2013 | 04-22-2013 | HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-460-2013 | 04-22-2013 | PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 2 | Class II | Terminated |
| D-472-2013 | 04-22-2013 | Chlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 1 | Class II | Terminated |
| D-469-2013 | 04-22-2013 | Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 1 | Class II | Terminated |
| D-474-2013 | 04-22-2013 | PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 2 | Class II | Terminated |
| D-481-2013 | 04-22-2013 | Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-484-2013 | 04-22-2013 | Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 11 | Class II | Terminated |
| D-494-2013 | 04-22-2013 | Meperidine 100mg/ml MDV, 5ml 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-493-2013 | 04-22-2013 | Lidocaine 2% Inj MDV, 20 ml 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-470-2013 | 04-22-2013 | Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-479-2013 | 04-22-2013 | HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-500-2013 | 04-22-2013 | Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India | Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets.. | Mylan Pharmaceuticals Inc. / 3,048 bottles | Class II | Terminated |
| D-480-2013 | 04-22-2013 | Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 7 | Class II | Terminated |
