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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-458-2013 | 04-22-2013 | PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml 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. / 37 | Class II | Terminated |
| D-466-2013 | 04-22-2013 | Super Trimix #1 Inj MDV, 12 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. / 1 | Class II | Terminated |
| D-467-2013 | 04-22-2013 | Vancomycin Opth Soln 25mg/ml PF, 10ml 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. / 2 | Class II | Terminated |
| D-492-2013 | 04-22-2013 | M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 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-482-2013 | 04-22-2013 | Hydroxycobalamin Inj 2500 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-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-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-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-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-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-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-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-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-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-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 |
| D-468-2013 | 04-22-2013 | Vancomycin Opth Soln 30mg/ml PRES, 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. / N/A | Class II | Terminated |
| D-490-2013 | 04-22-2013 | Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 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-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-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-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-491-2013 | 04-22-2013 | Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 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-483-2013 | 04-22-2013 | Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 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. / 14 | Class II | Terminated |
| D-488-2013 | 04-22-2013 | Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 5 | 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-453-2013 | 04-22-2013 | Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 5 | Class II | Terminated |
| D-454-2013 | 04-22-2013 | Bimix Inj 30:0.5 MDV, 5 ml syr 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. / 5 | Class II | Terminated |
| D-487-2013 | 04-22-2013 | Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 5 | Class II | Terminated |
| D-485-2013 | 04-22-2013 | Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr 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. / 2 | Class II | Terminated |
| D-457-2013 | 04-22-2013 | PGE-1 Inj 10mcg/ml MDV, 5ml 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-456-2013 | 04-22-2013 | Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr 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. / 8 | Class II | Terminated |
| D-471-2013 | 04-22-2013 | Tobramycin Opth Soln 13mg/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-486-2013 | 04-22-2013 | Methylcobalamin Inj 2.5mg/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. / 3 | Class II | Terminated |
| D-459-2013 | 04-22-2013 | PGE-1 Inj 30mcg/ml MDV, 7 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. / N/A | Class II | Terminated |
| D-495-2013 | 04-22-2013 | Pyridoxine 100mg/ml Inj MDV, 1X30 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-464-2013 | 04-22-2013 | Trimix Inj 30:3:5 MDV, 10ml 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. / 1 | Class II | Terminated |
| D-461-2013 | 04-22-2013 | Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 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-477-2013 | 04-22-2013 | HCG Inj 1200un/ml MDV, 10 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-463-2013 | 04-22-2013 | Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 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-473-2013 | 04-22-2013 | Dexamethasone Opth Soln 0.1% PF, 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. / 7 | Class II | Terminated |
| D-462-2013 | 04-22-2013 | Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 72 | Class II | Terminated |
| D-455-2013 | 04-22-2013 | Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 128 | Class II | Terminated |
| D-489-2013 | 04-22-2013 | Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 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-420-2013 | 04-19-2013 | Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85 | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. | Novartis Consumer Health / 3,828 Tubes | Class III | Terminated |
| D-0251-2015 | 04-19-2013 | Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX | Non-Sterility | Abrams Royal Pharmacy / 50 syringes | Class I | Terminated |
| D-298-2013 | 04-19-2013 | GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21. | Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level. | Qualitest Pharmaceuticals / 10,373 bottles | Class II | Terminated |
| D-268-2013 | 04-18-2013 | Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles. Package NDCs: 0781-2020-31; 0781-2020-76; 0781-2020-01; 0781-2020-05; 0781-2613-31; 0781-2613-76; 0781-2613-01; 0781-2613-05; 0781-5060-20; 0781-5060-01; 0781-5061-20; 0781-5061-01; 0781-6039-58; 0781-6039-46; 0781-6039-55; 0781-6156-52; 0781-6156-57; 0781-6156-46; 0781-6041-58; 0781-6041-46; 0781-6041-55; 0781-6157-52; 0781-6157-57; 0781-6157-46 | Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh. | Sandoz Incorporated / 8286 x 30 ct, 37108 x 500 ct. bottles | Class II | Terminated |
| D-286-2013 | 04-17-2013 | 17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 4 vials (5 mL each) | Class II | Terminated |
| D-284-2013 | 04-17-2013 | BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 6 vials (5 mL and 10 mL each) | Class II | Terminated |
| D-287-2013 | 04-17-2013 | QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 3 vials (10 mL each) | Class II | Terminated |
| D-288-2013 | 04-17-2013 | DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 2 50 mL vials | Class II | Terminated |
| D-1587-2014 | 04-17-2013 | NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502 | Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production. | Unique Pharmaceutical, Ltd / 430 Bags | Class II | Terminated |
| D-285-2013 | 04-17-2013 | Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 3 vials (10 mL vials) | Class II | Terminated |
| D-283-2013 | 04-17-2013 | BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / | Class II | Terminated |
| D-278-2013 | 04-17-2013 | Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 12 vials (15 mL each) | Class II | Terminated |
| D-274-2013 | 04-17-2013 | Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 28 vials (10 mL each) | Class II | Terminated |
| D-290-2013 | 04-17-2013 | Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 172 vials (5 mL vials each) | Class II | Terminated |
