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-118-2013 | 09-26-2012 | Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / 10,865 vials | Class II | Terminated |
| D-114-2013 | 09-26-2012 | Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / N/A | Class II | Terminated |
| D-111-2013 | 09-26-2012 | Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA | Non-Sterility | New England Compounding Center / 3822 vials | Class I | Terminated |
| D-112-2013 | 09-26-2012 | Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / N/A | Class II | Terminated |
| D-108-2013 | 09-26-2012 | Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA | Non-Sterility | New England Compounding Center / 23,897 vials | Class I | Terminated |
| D-120-2013 | 09-26-2012 | Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / N/A | Class II | Terminated |
| D-119-2013 | 09-26-2012 | Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / 7055 vials | Class II | Terminated |
| D-123-2013 | 09-26-2012 | Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA | Lack of Assurance of Sterility | New England Compounding Center / 54 vials | Class II | Terminated |
| D-110-2013 | 09-26-2012 | Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA | Non-Sterility | New England Compounding Center / 5130 vials | Class I | Terminated |
| D-058-2013 | 09-21-2012 | Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05. | Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets. | Watson Laboratories Inc / 4,874 bottles | Class I | Terminated |
| D-1686-2012 | 09-21-2012 | 5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). | Baxter Healthcare Corp. / 753,941 containers | Class II | Terminated |
| D-062-2013 | 09-21-2012 | Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | American Enterprises LLC dba Sterling Gelatin / 750 kgs | Class II | Terminated |
| D-1690-2012 | 09-21-2012 | Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). | Baxter Healthcare Corp. / 55,664 containers | Class II | Terminated |
| D-1689-2012 | 09-21-2012 | 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). | Baxter Healthcare Corp. / 897,496 containers | Class II | Terminated |
| D-1688-2012 | 09-21-2012 | 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03 | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). | Baxter Healthcare Corp. / 5,064 containers | Class II | Terminated |
| D-1687-2012 | 09-21-2012 | 10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03 | Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP). | Baxter Healthcare Corp. / 2,976 containers | Class II | Terminated |
| D-087-2013 | 09-20-2012 | Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01 | Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery). | Genentech Inc / 10,306 syringes | Class II | Terminated |
| D-088-2013 | 09-20-2012 | Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01 | Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery). | Genentech Inc / 12,791 syringes | Class II | Terminated |
| D-148-2013 | 09-20-2012 | SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873 | Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug. | Globe All Wellness, LLC / 40,400 bottles | Class I | Terminated |
| D-008-2013 | 09-20-2012 | Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33 Package NDCs: 0781-5283-06; 0781-5283-64; 0904-5878-33 | Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2) | Sandoz Incorporated / 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons | Class III | Terminated |
| D-035-2013 | 09-17-2012 | UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403 | Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification. | DermaCare, Inc. / 43,272 bottles | Class II | Terminated |
| D-034-2013 | 09-17-2012 | UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403 | Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification. | DermaCare, Inc. / 25,956 bottles | Class II | Terminated |
| D-1678-2012 | 09-12-2012 | Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92 | Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing. | Sandoz Incorporated / 41,761bottles. | Class III | Terminated |
| D-1677-2012 | 09-12-2012 | Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92, | Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing. | Sandoz Incorporated / 43,060 x 90 count bottles | Class III | Terminated |
| D-057-2013 | 09-10-2012 | HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21 | Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals / 14,445 bottles | Class I | Ongoing |
| D-061-2013 | 09-06-2012 | Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7. | CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG. | Church & Dwight Inc / 42,768 pumps | Class II | Terminated |
| D-105-2013 | 09-05-2012 | Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom | Lack of Assurance of Sterility; container closure issues with the bulk batch. | F. Hoffmann-LaRoche Ltd. / 42010 vials | Class II | Terminated |
| D-030-2013 | 09-04-2012 | Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Relieves Constipation, Restores Regularity, 160 Capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL 33431, UPC0-40986-01703-2 | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 1,440 bottles | Class II | Terminated |
| D-026-2013 | 09-04-2012 | Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative/Supplement, a)160 capsules per bottle (item #503663), and b) 320 capsules per bottle (Item #586143), Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616, www.walgreens.com, a) UPC 3-11917-08151-9, b) UPC 3-11917-07658-4 | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 56,808 bottles | Class II | Terminated |
| D-029-2013 | 09-04-2012 | Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement, Fiber Laxative for Regularity, 400 capsules per bottle, Distributed by: SAM'S West, Inc., Bentonville, AR 72716, UPC 0-78742-00524-9. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 46,104 bottles | Class II | Terminated |
| D-031-2013 | 09-04-2012 | Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL, UPC 8-40986-01987-6 | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 96 bottles | Class II | Terminated |
| D-027-2013 | 09-04-2012 | Wal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psyllium Seed Husk, Calcium/Dietary Fiber Supplement, 240 Capsules per bottle, Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616 www.walgreens.com, NDC 0363-0128-24, UPC 3-11917-07656-0. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 7,608 bottles | Class II | Terminated |
| D-022-2013 | 09-04-2012 | CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per bottle, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895 www.cvs.com UPC 0-50428-07739-9 | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 16,848 bottles | Class II | Terminated |
| D-024-2013 | 09-04-2012 | Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH 43017 www.myleader.com, NDC 37205-372-78, UPC 0-96295-11222-1. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 2,988 bottles | Class II | Terminated |
| D-032-2013 | 09-04-2012 | DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 17,136 bottles | Class II | Terminated |
| D-025-2013 | 09-04-2012 | Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Distributed by: Target Corp., Minneapolis, MN 55403, Made in USA, NDC 11673-059-87, UPC 3-68163-11926-8. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 48,120 bottles | Class II | Terminated |
| D-028-2013 | 09-04-2012 | Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC 4-00016-27053-2. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 3,552 bottles | Class II | Terminated |
| D-021-2013 | 09-04-2012 | Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative, 100 capsules per bottle, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, KS 06106, UPC 0-70038-63439-3 | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 2160 bottles | Class II | Terminated |
| D-023-2013 | 09-04-2012 | Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 capsules per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 68163-119-60, UPC 6-81131-77922-7. | Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material. | Raritan Pharmaceuticals, Inc. / 183,141 bottles | Class II | Terminated |
| D-1683-2012 | 09-04-2012 | Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30 | Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength. | Apace KY LLC / 81,516 bottles | Class III | Terminated |
| D-922-2013 | 08-31-2012 | 0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23 | Presence of Particulate Matter; product may contain fibrous material | Hospira Inc. / 264,432 bags | Class I | Terminated |
| D-012-2013 | 08-29-2012 | BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Diluent manufactured by: Luitpold Pharmaceuticals, Inc. Shirley, NY 11967 Distributed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA Made in USA NDC 0015-3012-18 NDC 0015-3012-60 | Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot. | Bristol-myers Squibb Company / 31,481 kits | Class I | Terminated |
| D-1685-2012 | 08-29-2012 | Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25 | Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection. | Hospira Inc. / 148,630 vials | Class II | Terminated |
| D-309-2013 | 08-28-2012 | 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. / 172,350 vials | Class II | Terminated |
| D-308-2013 | 08-28-2012 | Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12 Package NDCs: 0409-3814-11; 0409-3814-12; 0409-3815-11; 0409-3815-12 | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial | Hospira Inc. / 26,100 vials | Class II | Terminated |
| D-1691-2012 | 08-28-2012 | Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947 | Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol | Dispensing Solutions, Inc / 18 Inhalers | Class II | Terminated |
| D-129-2013 | 08-28-2012 | I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031 | Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use. | James G. Cole, Inc. / 253 bottles | Class II | Terminated |
| D-063-2013 | 08-27-2012 | Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish) | Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug. | Samantha Lynn, Inc / 25,888 Boxes | Class I | Terminated |
| D-051-2013 | 08-23-2012 | Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30 | Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules." | Stat Rx USA / 5 bottles | Class III | Terminated |
| D-328-2013 | 08-23-2012 | Mojo Nights for Her, 1 capsule, UPC 7 18122 12133 5, Distributed By: Mojo Health Lauderhill, FL 33351 | Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs. | Evol Nutrition / 1000 blister packs (total both products) | Class I | Terminated |
| D-327-2013 | 08-23-2012 | Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351 | Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs. | Evol Nutrition / 1000 blister packs (total both products) | Class I | Terminated |
| D-073-2013 | 08-23-2012 | Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 Manufactured by: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada. NDC # 55566-1501-0 is assigned to the vial of NOVAREL and is displayed on the vial label. NDC # 55566-1501-1 is assigned to the unit of sale, which is a carton containing 1 vial of NOVAREL and 1 vial of diluent along with the insert. NDC # 55566-1501-1 is displayed on the unit of sale and is the item subject to recall. | Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products. | Ferring Pharmaceuticals Inc / 146,867 Vials | Class III | Terminated |
| D-060-2013 | 08-21-2012 | Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90 Package NDCs: 63304-828-90; 63304-828-05; 63304-827-90; 63304-827-05; 63304-829-90; 63304-829-05; 63304-830-90; 63304-830-05 | Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg. | Ranbaxy Inc. / 32,208 bottles | Class II | Terminated |
| D-003-2013 | 08-21-2012 | Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc. | Crystallization: Presence of crystals of Nimodipine within the capsule solution. | Caraco Pharmaceutical Laboratories Ltd. / a) 2424 Cartons b) 2675 Cartons | Class II | Terminated |
| D-134-2013 | 08-17-2012 | Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03 | Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging. | Axcentria Pharmaceuticals LLC / 17,679 bottles | Class III | Terminated |
| D-1660-2012 | 08-15-2012 | Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04, | Subpotent; fluocinolone acetonide. | Galderma Laboratories, L.P. / 17,160 bottles | Class III | Terminated |
| D-020-2013 | 08-15-2012 | HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit). Package NDCs: 0409-2552-11; 0409-2552-01; 0409-3356-11; 0409-3356-01; 0409-2540-11; 0409-2540-01; 0409-3365-11; 0409-3365-01; 0409-3365-10; 0409-1283-03; 0409-1283-31; 0409-1312-03; 0409-1312-30; 0409-1304-03; 0409-1304-31 | Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume. | Hospira Inc. / 216,880 cartridge units | Class I | Terminated |
| D-095-2013 | 08-14-2012 | Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543, by Hollister-Stier Laboratories LLC, Spokane Washington 99207, NDC 0270-0083-20. Package NDCs: 0270-0083-20 | Presence of Particulate Matter; potential for charcoal particulates | Bracco Diagnostic Inc / 196,280 Vials | Class III | Terminated |
| D-006-2013 | 08-14-2012 | Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC 0472-1629-16 | Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant. | Actavis Mid Atlantic LLC / 19,980 Bottles | Class III | Terminated |
| D-005-2013 | 08-14-2012 | Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16. | Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant. | Actavis Mid Atlantic LLC / 14,868 Bottles | Class III | Terminated |
| D-033-2013 | 08-07-2012 | Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** Carole Park QLD 4300, Australia*** Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.SA *** | Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine. | Mylan Pharmaceuticals Inc. / 24,331 bottles | Class II | Terminated |
| D-1672-2012 | 08-03-2012 | Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24 Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25 | Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection. | Hospira Inc. / 56,420 vials | Class II | Terminated |
| D-178-2013 | 08-01-2012 | Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-342-30 | Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell. | Dr. Reddy's Laboratories, Inc. / 27,805 bottles | Class II | Terminated |
| D-179-2013 | 08-01-2012 | Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-343-30 | Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell. | Dr. Reddy's Laboratories, Inc. / 86, 093 bottles | Class II | Terminated |
| D-180-2013 | 08-01-2012 | Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-344-30 | Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell. | Dr. Reddy's Laboratories, Inc. / 48, 754 bottles (C108376)/47,520 bottles (C108634) | Class II | Terminated |
| D-1692-2012 | 07-30-2012 | Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration, 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol as a preservative, RX, Mallinckrodt Inc., St. Louis, MO 63134 | Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label) | Mallinckrodt Inc / 12/2.8mCi-vials and 12/6.3mCi-vials | Class III | Terminated |
| D-135-2013 | 07-30-2012 | Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit; Investigation Use only, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080-4990. | Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates. | Genentech Inc / 2,140 kits | Class I | Terminated |
| D-1671-2012 | 07-27-2012 | Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2. | Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia. | Natural Essentials Inc / 11,058 bottles | Class III | Terminated |
| D-1664-2012 | 07-27-2012 | Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541 | Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria. | Capco Custom Packaging Inc / 14380 Bottles | Class II | Terminated |
| D-1702-2012 | 07-27-2012 | Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05 Package NDCs: 0378-5615-78; 0378-5615-05; 0378-5617-78; 0378-5617-05; 0378-5619-91 | Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg. | Mylan Pharmaceuticals Inc. / 960 bottles | Class II | Terminated |
| D-1666-2012 | 07-26-2012 | Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20 Package NDCs: 0173-0682-20; 0173-0682-24 | Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. | GlaxoSmithKline Inc / 1,412,566 inhalers | Class II | Terminated |
| D-103-2013 | 07-25-2012 | Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. | Subpotent; 9-month stability interval | Lloyd Inc. of Iowa / 16,548/100-tablet bottles | Class II | Terminated |
| D-102-2013 | 07-25-2012 | Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA | Subpotent; 9-month stability interval | Lloyd Inc. of Iowa / 1,924,133/75-mcg. tablets | Class II | Terminated |
| D-101-2013 | 07-25-2012 | Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. | Subpotent; 9-month stability interval | Lloyd Inc. of Iowa / 37,441/100-tablet bottles | Class II | Terminated |
| D-100-2013 | 07-25-2012 | Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | Subpotent; 9-month stability interval | Lloyd Inc. of Iowa / 3,789,426/50-mcg. tablets | Class II | Terminated |
| D-1645-2012 | 07-25-2012 | Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd., Ahmedabad, India; Dist By: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, Pkg by: American Health Packaging, Col. OH 43217, NDC 68084-343-21, blister barcode 6808434311 | Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets". | American Health Packaging / 1,170 cartons | Class III | Terminated |
| D-1432-2012 | 07-24-2012 | OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only, Manufactured for: Cadence Pharmaceuticals, Inc., San Diego, CA 92130, NDC 43825-102-01, UPC 3 43825 10201 7. | Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter. | Cadence Pharmaceuticals / 1,098,912 vials | Class II | Terminated |
| D-1668-2012 | 07-23-2012 | Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American Health Packaging, 2550-A John Glenn Avenue, Columbus, OH 43217, barcode 6808432511; Carton labeling Dist by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977, NDC 68084-325-21. | Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution. | American Health Packaging / 694 cartons | Class II | Terminated |
| D-1650-2012 | 07-23-2012 | CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description. | Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags. | Custom Medical Specialties, Inc. / 20 Trays | Class II | Terminated |
| D-1651-2012 | 07-23-2012 | CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568, the tray also contains other components not listed in this product description. | Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags. | Custom Medical Specialties, Inc. / 25 Trays | Class II | Terminated |
| D-1649-2012 | 07-23-2012 | Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description. | Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags | Custom Medical Specialties, Inc. / 35 Trays | Class II | Terminated |
| D-1427-2012 | 07-23-2012 | Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90. | Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label. | Stat Rx USA / 51 Bottles | Class III | Terminated |
| D-1695-2012 | 07-19-2012 | Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90. Package NDCs: 0074-4341-13; 0074-4341-90; 0074-4341-19; 0074-4341-72; 0074-4552-13; 0074-4552-90; 0074-4552-19; 0074-4552-11; 0074-4552-71; 0074-4552-72; 0074-5182-13; 0074-5182-90; 0074-5182-71; 0074-5182-19; 0074-5182-11; 0074-5182-72; 0074-6594-13; 0074-6594-90; 0074-6594-71; 0074-6594-19; 0074-6594-72; 0074-6624-13; 0074-6624-90; 0074-6624-19; 0074-6624-11; 0074-6624-71; 0074-6624-72; 0074-9296-13; 0074-9296-90; 0074-9296-19; 0074-9296-71; 0074-9296-72; 0074-7068-13; 0074-7068-90; 0074-7068-71; 0074-7068-19; 0074-7068-11; 0074-7068-72; 0074-3727-13; 0074-3727-90; 0074-3727-71; 0074-3727-19; 0074-3727-72; 0074-7069-90; 0074-7069-71; 0074-7069-19; 0074-7069-11; 0074-7069-72; 0074-7070-13; 0074-7070-90; 0074-7070-71; 0074-7070-19; 0074-7070-72; 0074-7148-90; 0074-7148-19; 0074-7148-71; 0074-7148-11; 0074-7148-72; 0074-7149-90; 0074-7149-19 | Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets. | Abbott Laboratories / 42,596 Bottles | Class II | Terminated |
| D-1694-2012 | 07-19-2012 | Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90. Package NDCs: 0074-4341-13; 0074-4341-90; 0074-4341-19; 0074-4341-72; 0074-4552-13; 0074-4552-90; 0074-4552-19; 0074-4552-11; 0074-4552-71; 0074-4552-72; 0074-5182-13; 0074-5182-90; 0074-5182-71; 0074-5182-19; 0074-5182-11; 0074-5182-72; 0074-6594-13; 0074-6594-90; 0074-6594-71; 0074-6594-19; 0074-6594-72; 0074-6624-13; 0074-6624-90; 0074-6624-19; 0074-6624-11; 0074-6624-71; 0074-6624-72; 0074-9296-13; 0074-9296-90; 0074-9296-19; 0074-9296-71; 0074-9296-72; 0074-7068-13; 0074-7068-90; 0074-7068-71; 0074-7068-19; 0074-7068-11; 0074-7068-72; 0074-3727-13; 0074-3727-90; 0074-3727-71; 0074-3727-19; 0074-3727-72; 0074-7069-90; 0074-7069-71; 0074-7069-19; 0074-7069-11; 0074-7069-72; 0074-7070-13; 0074-7070-90; 0074-7070-71; 0074-7070-19; 0074-7070-72; 0074-7148-90; 0074-7148-19; 0074-7148-71; 0074-7148-11; 0074-7148-72; 0074-7149-90; 0074-7149-19 | Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets. | Abbott Laboratories / 53,448 Bottles | Class II | Terminated |
| D-1696-2012 | 07-19-2012 | Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90 Package NDCs: 0074-4341-13; 0074-4341-90; 0074-4341-19; 0074-4341-72; 0074-4552-13; 0074-4552-90; 0074-4552-19; 0074-4552-11; 0074-4552-71; 0074-4552-72; 0074-5182-13; 0074-5182-90; 0074-5182-71; 0074-5182-19; 0074-5182-11; 0074-5182-72; 0074-6594-13; 0074-6594-90; 0074-6594-71; 0074-6594-19; 0074-6594-72; 0074-6624-13; 0074-6624-90; 0074-6624-19; 0074-6624-11; 0074-6624-71; 0074-6624-72; 0074-9296-13; 0074-9296-90; 0074-9296-19; 0074-9296-71; 0074-9296-72; 0074-7068-13; 0074-7068-90; 0074-7068-71; 0074-7068-19; 0074-7068-11; 0074-7068-72; 0074-3727-13; 0074-3727-90; 0074-3727-71; 0074-3727-19; 0074-3727-72; 0074-7069-90; 0074-7069-71; 0074-7069-19; 0074-7069-11; 0074-7069-72; 0074-7070-13; 0074-7070-90; 0074-7070-71; 0074-7070-19; 0074-7070-72; 0074-7148-90; 0074-7148-19; 0074-7148-71; 0074-7148-11; 0074-7148-72; 0074-7149-90; 0074-7149-19 | Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets. | Abbott Laboratories / 40,464 Bottles | Class II | Terminated |
| D-241-2013 | 07-18-2012 | Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15 Package NDCs: 0168-0099-15; 0168-0099-30; 0168-0099-60 | Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product | Fougera Pharmaceuticals Inc. / 60,210 units | Class III | Terminated |
| D-0319-2015 | 07-18-2012 | Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC --- Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, Item # 427594, NDC 0363-0428-12, UPC Code 311917134925 | Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label. | LNK International, Inc. / 9,379 bottles | Class II | Terminated |
| D-038-2013 | 07-16-2012 | X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale, FL, Also, labeled as X-Rock 3 Day Pill For Erectile Refunction, Distributed by www. CoralXRock.Com, Florida Keys, Florida | Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil. | Coral Rock Man, Inc. / unknown | Class I | Terminated |
| D-039-2013 | 07-16-2012 | Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066 | Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil. | Coral Rock Man, Inc. / unknown | Class I | Terminated |
| D-1670-2012 | 07-13-2012 | CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g. | Microbial Contamination of Non Sterile Product; mold | Island Kinetics dba Covalence / 5311 bottles | Class II | Terminated |
| D-1441-2012 | 07-12-2012 | Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30, | Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014 | Axcentria Pharmaceuticals LLC / 13,128 bottles | Class III | Terminated |
| D-1653-2012 | 07-12-2012 | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 177,900 patches | Class II | Terminated |
| D-1655-2012 | 07-12-2012 | Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 231,270 patches | Class II | Terminated |
| D-1654-2012 | 07-12-2012 | Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5555-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 121,530 patches | Class II | Terminated |
| D-1693-2012 | 07-11-2012 | Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc. | Subpotent; some patches may not contain fentanyl gel | Actavis / 98,088 cartons (5 pouches per carton) | Class II | Terminated |
| D-082-2013 | 07-09-2012 | Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP Deviations; does not meet in process specification requirements | Lloyd Inc. of Iowa / 3,774,541 tablets | Class II | Terminated |
| D-079-2013 | 07-09-2012 | Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. | cGMP Deviations; does not meet in process specification requirements | Lloyd Inc. of Iowa / 37,827/100-tablet bottles | Class II | Terminated |
| D-083-2013 | 07-09-2012 | Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. | cGMP Deviations; does not meet in process specification requirements | Lloyd Inc. of Iowa / 36,978/100-tablet bottles | Class II | Terminated |
| D-074-2013 | 07-09-2012 | Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP Deviations; does not meet in process specification requirements | Lloyd Inc. of Iowa / 1,923,887 tablets | Class II | Terminated |
| D-076-2013 | 07-09-2012 | Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP Deviations; does not meet in process specification requirements | Lloyd Inc. of Iowa / 3,826,269 tablets | Class II | Terminated |
