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-1297-2014 | 04-09-2014 | Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83 | Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide | Caraco Pharmaceutical Laboratories, Ltd. / 47,813 bottles | Class III | Terminated |
| D-1296-2014 | 04-09-2014 | Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83 | Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide | Caraco Pharmaceutical Laboratories, Ltd. / 128,363 bottles | Class III | Terminated |
| D-1407-2014 | 04-09-2014 | Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40 | Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance. | Caraco Pharmaceutical Laboratories, Ltd. / 200 vials | Class II | Terminated |
| D-1363-2014 | 04-09-2014 | Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61 | Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets | Legacy Pharmaceutical Packaging / unknown | Class II | Terminated |
| D-1594-2014 | 04-09-2014 | THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA. | Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. | Nature's Universe / Unknown | Class I | Terminated |
| D-1253-2014 | 04-08-2014 | Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60 | Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg). | Pfizer Inc. / 23,064 bottles | Class II | Terminated |
| D-1325-2014 | 04-07-2014 | BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2. | Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. | Teva Pharmaceuticals USA / 53,452 bottles | Class II | Terminated |
| D-1324-2014 | 04-07-2014 | BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5. | Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. | Teva Pharmaceuticals USA / 17,181 bottles | Class II | Terminated |
| D-1262-2014 | 04-07-2014 | Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA 18017. NDC: 66794-015-25. Package NDCs: 66794-015-25 | Failed pH Specifications: product was too acidic. | Piramal Critical Care, Inc. / 12,600 bottles | Class II | Terminated |
| D-1314-2014 | 04-04-2014 | Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11 Package NDCs: 0054-4581-27; 0054-4581-11 | Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months. | Boehringer Ingelheim Roxane Inc / 98,560 bottles | Class III | Terminated |
| D-1313-2014 | 04-04-2014 | Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25 | Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months. | Boehringer Ingelheim Roxane Inc / 8,304 bottles | Class III | Terminated |
| D-1547-2014 | 04-02-2014 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30 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 glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution. | Hospira Inc. / 844,300 vials | Class I | Terminated |
| D-1300-2014 | 04-01-2014 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1. | Failed Dissolution Specifications: failure of dissolution test observed at nine month time point. | Wockhardt Usa Inc. / 109,744 bottles | Class II | Terminated |
| D-0048-2015 | 04-01-2014 | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702-052-16, Rx Only, Manufactured for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. | Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station. | Hi-Tech Pharmacal Co., Inc. / 451,916 bottles | Class II | Terminated |
| D-1315-2014 | 04-01-2014 | PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10. | Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate. | Konsyl Pharmaceuticals Inc / 6286 Bottles | Class III | Terminated |
| D-1285-2014 | 04-01-2014 | Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2 | Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser. | Genesis Pharmaceutical, Inc. / 461 Bottles | Class III | Terminated |
| D-1499-2014 | 04-01-2014 | triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78 | Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole. | Teva Pharmaceuticals USA / 89,215 blister pack | Class II | Terminated |
| D-1602-2014 | 03-28-2014 | XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orlando, FL 32789 | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1600-2014 | 03-28-2014 | Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los Angeles, CA 90012 | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1598-2014 | 03-28-2014 | XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los Angeles, CA 90012 | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1601-2014 | 03-28-2014 | Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orlando, FL 32789 | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone 1200because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1597-2014 | 03-28-2014 | Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering Co., Ltd, USA., | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Black Ant because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1596-2014 | 03-28-2014 | AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City. | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1603-2014 | 03-28-2014 | MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663 | Marketed Without an Approved NDA/ANDA; Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1599-2014 | 03-28-2014 | XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City of Los Angeles, CA 90012 | Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN PLATINUM because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. | Nova Products, Inc. / Unknown | Class I | Terminated |
| D-1423-2014 | 03-28-2014 | Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709 | Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may have been programmed with a different software version than intended for the device. If the device has the incorrect software, it may not operate as indicated in the Instructions for Use. | United Therapeutics Corp. / 188 Units | Class II | Terminated |
| D-1261-2014 | 03-27-2014 | Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA | Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide | Hospira Inc. / 255,900 vials | Class II | Terminated |
| D-1230-2014 | 03-27-2014 | Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany. Package NDCs: 0597-0075-41; 0597-0075-75; 0597-0075-47 | Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell. | Boehringer Ingelheim Roxane Inc / 1,276,710 Blister Cards | Class III | Terminated |
| D-1362-2014 | 03-26-2014 | Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69. | Superpotent Drug: Product contains twice the stated amount of midazolam. | Pharmakon Pharmaceuticals / 80 syringes | Class I | Terminated |
| D-1226-2014 | 03-25-2014 | Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc., Lake Forest, IL. | Labeling; Missing label; ampoules are missing the immediate container label | Hospira Inc. / 237,850 ampoules | Class III | Terminated |
| D-0315-2015 | 03-25-2014 | New Life Nutritional SUPER FAT BURNER, bottle contains 30 CAPSULES, product is packaged in a white plastic bottle with black, red and green font. Distributed by: New Life Nutritional under the following addresses: 714 West 181st Street New York, NY 10033, 153 East 188th Street Bronx, NY 10468, 316 Monroe Street Passaic, NJ 07055 and 200 Dyckman Street New York, NY 10040. | Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs. | New Life Nutritional Center / 14 bottles | Class I | Terminated |
| D-0317-2015 | 03-25-2014 | Esmeralda, bottle contains 30 Softgels, product is packaged in a white plastic bottle with green labeling and black font. Distributed by: New Life Nutritional, www.newlifenutritional.com under the following addresses: 714 West 181st Street NY, NY 10033, 200-9 Dyckman Street NY, NY 10040, 153 East 188th Street Bronx, NY 10468 and 316 Monroe Street Passaic, NJ 07055. | Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs. | New Life Nutritional Center / 2 bottles | Class I | Terminated |
| D-0316-2015 | 03-25-2014 | MAXI GOLD WEIGHT LOSS PILL, bottle contains 30 CAPSULES, product is packaged in a clear plastic bottle with blue lid, gold and orange label with orange font. Distributed by: New Life nutritional, www.newlifenutritional.com under the following telephone numbers: (212) 923-6386, (212) 304-8880, (718) 329-1636 and (862) 591-2188. | Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs. | New Life Nutritional Center / 13 bottles | Class I | Terminated |
| D-1323-2014 | 03-25-2014 | Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA | First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets). | First Aid Only Inc / 802 | Class II | Terminated |
| D-1293-2014 | 03-24-2014 | GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05 | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements | Teva Pharmaceuticals USA / 2532 bottles | Class II | Terminated |
| D-1295-2014 | 03-24-2014 | INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. | Teva Pharmaceuticals USA / 5812 bottles | Class II | Terminated |
| D-1294-2014 | 03-24-2014 | INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01 | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements | Teva Pharmaceuticals USA / 7,694 bottles | Class II | Terminated |
| D1292-2014 | 03-24-2014 | METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01 | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements | Teva Pharmaceuticals USA / 22820 bottles | Class II | Terminated |
| D-1580-2014 | 03-24-2014 | PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3663-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1581-2014 | 03-24-2014 | PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3664-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1582-2014 | 03-24-2014 | PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3666-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1575-2014 | 03-24-2014 | PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / 13,429 bottles | Class II | Terminated |
| D-1578-2014 | 03-24-2014 | PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3 Package NDCs: 60505-4377-3; 60505-4378-3; 60505-4379-3; 60505-3668-3; 60505-3669-3; 60505-3670-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1579-2014 | 03-24-2014 | PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3670-3 Package NDCs: 60505-4377-3; 60505-4378-3; 60505-4379-3; 60505-3668-3; 60505-3669-3; 60505-3670-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1577-2014 | 03-24-2014 | Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3 Package NDCs: 60505-1316-3; 60505-1317-3; 60505-1318-3; 60505-3673-3; 60505-3674-3; 60505-3675-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1576-2014 | 03-24-2014 | Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3 Package NDCs: 60505-1316-3; 60505-1317-3; 60505-1318-3; 60505-3673-3; 60505-3674-3; 60505-3675-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1574-2014 | 03-24-2014 | Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3 Package NDCs: 60505-1316-3; 60505-1317-3; 60505-1318-3; 60505-3673-3; 60505-3674-3; 60505-3675-3 | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. | Apotex Inc. / | Class II | Terminated |
| D-1354-2014 | 03-21-2014 | ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY | Non-sterility: due to a failed sterility test | Teva Pharmaceuticals USA / 47890 | Class II | Terminated |
| D-1299-2014 | 03-20-2014 | Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1. | Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point. | Apotex Inc. / 11,422 bottles | Class III | Terminated |
| D-1283-2014 | 03-20-2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. | Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications. | Caraco Pharmaceutical Laboratories, Ltd. / 160,105 bottles | Class II | Terminated |
| D-1284-2014 | 03-20-2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. | Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications. | Caraco Pharmaceutical Laboratories, Ltd. / 91,777 bottles | Class II | Terminated |
| D-1229-2014 | 03-18-2014 | Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8, NDC 68462-248-05. | Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg. | Glenmark Generics Inc., USA / 2904 bottles | Class II | Terminated |
| D-1259-2014 | 03-17-2014 | Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203. | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | John W Hollis Inc / 2 vials | Class III | Terminated |
| D-1257-2014 | 03-17-2014 | Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203. | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | John W Hollis Inc / 7 vials | Class II | Terminated |
| D-1260-2014 | 03-17-2014 | Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203. | Presence of Particulate Matter | John W Hollis Inc / 3 vials | Class II | Terminated |
| D-1258-2014 | 03-17-2014 | Papaverine 60 mg, Phentolamine 4 mg, and Atropine 0.3 mg Solution, 10 mL Vial, Rx Only. Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203. | Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial. | John W Hollis Inc / 1 vial | Class III | Terminated |
| D-1251-2014 | 03-14-2014 | VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04. Package NDCs: 54092-701-04 | Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate. | Shire Human Genetic Therapies, Inc. / 8359 vials | Class I | Terminated |
| D-1322-2014 | 03-13-2014 | REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original. | Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol. | Pain Free By Nature / 7,123 bottles | Class I | Terminated |
| D-1301-2014 | 03-13-2014 | Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05 | Defective container: Product distributed without inner seal on bottles. | Blu Pharmaceuticals Inc / 14,000 tablets | Class II | Terminated |
| D-1302-2014 | 03-13-2014 | Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05 | Defective container: Product distributed without inner seal on bottles. | Blu Pharmaceuticals Inc / 101,500 tablets | Class II | Terminated |
| D-1168-2014 | 03-11-2014 | Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01 | Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml. | Paddock Laboratories, LLC / 156,012 bottles | Class II | Terminated |
| D-1290-2014 | 03-10-2014 | Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-Month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3663-03, UPC 3 00743 66303 7. Package NDCs: 0074-3663-03 | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. | AbbVie Inc / 1,530 kits | Class II | Terminated |
| D-1288-2014 | 03-10-2014 | Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 45 mg for 6-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3473-03, UPC 3 00743 47303 2. Package NDCs: 0074-3473-03; 0074-3473-55; 0074-9945-01; 0074-0009-01; 0074-3683-03; 0074-3683-55; 0074-9930-01; 0074-3642-03; 0074-3642-55; 0074-9907-01; 0074-3346-03; 0074-3346-55; 0074-9922-01 | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. | AbbVie Inc / 36 kits | Class II | Terminated |
| D-1287-2014 | 03-10-2014 | Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3346-03, UPC 3 00743 34603 9. Package NDCs: 0074-3473-03; 0074-3473-55; 0074-9945-01; 0074-0009-01; 0074-3683-03; 0074-3683-55; 0074-9930-01; 0074-3642-03; 0074-3642-55; 0074-9907-01; 0074-3346-03; 0074-3346-55; 0074-9922-01 | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. | AbbVie Inc / 7362 kits | Class II | Terminated |
| D-1289-2014 | 03-10-2014 | LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3779-03, UPC 3 00743 77903 5. Package NDCs: 0074-2108-03; 0074-2282-03; 0074-2440-03; 0074-3779-03; 0074-9694-03; 0074-3575-01; 0074-3410-01; 0074-0010-01 | Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device. | AbbVie Inc / 12 kits | Class II | Terminated |
| D-1291-2014 | 03-10-2014 | Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 7.5 mg for 1-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3642-03, UPC 3 00743 64203 2. Package NDCs: 0074-3473-03; 0074-3473-55; 0074-9945-01; 0074-0009-01; 0074-3683-03; 0074-3683-55; 0074-9930-01; 0074-3642-03; 0074-3642-55; 0074-9907-01; 0074-3346-03; 0074-3346-55; 0074-9922-01 | Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device. | AbbVie Inc / 2915 kits | Class II | Terminated |
| D-1328-2014 | 03-06-2014 | Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101. | Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule. | Pfizer Us Pharmaceutical Group / 49,847 bottles | Class I | Terminated |
| D-1361-2014 | 03-06-2014 | Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9. | Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot | Greenstone Llc / 16,018 bottles | Class I | Terminated |
| D-1183-2014 | 03-04-2014 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7543-56 | Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. | Teva Pharmaceuticals USA / 598,033 Bottles | Class II | Terminated |
| D-1182-2014 | 03-04-2014 | Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06 | Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. | Teva Pharmaceuticals USA / 127,585 Bottles | Class II | Terminated |
| D-1184-2014 | 03-04-2014 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7544-56 | Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage. | Teva Pharmaceuticals USA / 324,648 Bottles | Class II | Terminated |
| D-1556-2014 | 03-04-2014 | VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451. Package NDCs: 65757-300-01; 65757-302-02; 65757-304-03; 65757-301-01; 65757-303-02; 65757-305-03 | Customer complaints for failure to deliver the dose. | Alkermes, Inc. / 4,364 vials | Class II | Terminated |
| D-1615-2014 | 03-04-2014 | Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intravenous Infusion, Mfd. for Sagent Pharmaceuticals Schaumburg, IL ---- NDC 25021-830-82 Package NDCs: 25021-830-82; 25021-830-87 | Lack of Assurance of Sterility; leaking of premix bags | Sagent Pharmaceuticals Inc / 10,622 bags | Class II | Terminated |
| D-1228-2014 | 03-03-2014 | Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901 Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0441-05 Package NDCs: 0078-0439-05; 0078-0440-05; 0078-0441-05 | Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t | Novartis Pharmaceuticals Corp. / 10,781 bottles | Class III | Terminated |
| D-1227-2014 | 03-03-2014 | Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901, Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0440-05 Package NDCs: 0078-0439-05; 0078-0440-05; 0078-0441-05 | Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t | Novartis Pharmaceuticals Corp. / 10,930 Bottles | Class III | Terminated |
| D-1193-2014 | 03-03-2014 | Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 7408 cartons | Class II | Terminated |
| D-1197-2014 | 03-03-2014 | Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-2 . | Penicillin Cross Contamination | Terra-Medica Inc. / 55 10 x 1 mL Cartons; 51 50 x 1 mL Cartons | Class II | Terminated |
| D-1212-2014 | 03-03-2014 | Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-0011-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 428 bottles | Class II | Terminated |
| D-1209-2014 | 03-03-2014 | Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1001-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 5940 Packages | Class II | Terminated |
| D-1192-2014 | 03-03-2014 | Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2304-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 4860 cartons | Class II | Terminated |
| D-1208-2014 | 03-03-2014 | Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1102-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 4770 Cartons | Class II | Terminated |
| D-1210-2014 | 03-03-2014 | Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 3440 bottles | Class II | Terminated |
| D-1206-2014 | 03-03-2014 | Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-1. Pleo Fort PORTABLE SIPS 5X, 50 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-2. | Penicillin Cross Contamination. | Terra-Medica Inc. / 126 10 x 1 ml Cartons; 76 50 x 1ml Cartons | Class II | Terminated |
| D-1191-2014 | 03-03-2014 | Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2305-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 1368 tubes | Class II | Terminated |
| D-1199-2014 | 03-03-2014 | Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Made in Germany, Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, Hoya, Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. NDC: 49807-0031-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 6120 cartons | Class II | Terminated |
| D-1203-2014 | 03-03-2014 | Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-1. Pleo Quent PORTABLE SIPS 5X, 50 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-2. | Penicillin Cross Contamination | Terra-Medica Inc. / 211 10 x 1 ml vials; 152 50 x 1 vials | Class II | Terminated |
| D-1195-2014 | 03-03-2014 | Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2301-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 21,445 Bottles | Class II | Terminated |
| D-1202-2014 | 03-03-2014 | Pleo Quent DROPS 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2901-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 10,725 bottles | Class II | Terminated |
| D-1207-2014 | 03-03-2014 | Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1101-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 8405 bottles | Class II | Terminated |
| D-1205-2014 | 03-03-2014 | Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1103-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 4050 cartons | Class II | Terminated |
| D-1200-2014 | 03-03-2014 | Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2904-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 3725 cartons | Class II | Terminated |
| D-1196-2014 | 03-03-2014 | Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-2. | Penicillin Cross Contamination | Terra-Medica Inc. / 730 10 x 1mL Cartons; 367 50 x 1 mL Cartons | Class II | Terminated |
| D-1204-2014 | 03-03-2014 | Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1106-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 2147 cartons | Class II | Terminated |
| D-1194-2014 | 03-03-2014 | Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2302-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 4955 cartons | Class II | Terminated |
| D-1201-2014 | 03-03-2014 | Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG NDC: 49807-2902-1. | Penicillin Cross Contamination | Terra-Medica Inc. / 3066 cartons | Class II | Terminated |
| D-1211-2014 | 03-03-2014 | Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-2. | Penicillin Cross Contamination | Terra-Medica Inc. / 111 10 x 1 mls; 39 50 x 1 mls | Class II | Terminated |
| D-1198-2014 | 03-03-2014 | Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-1. Pleo Not PORTABLE SIPS 7X, 50 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-2. | Penicillin Cross Contamination | Terra-Medica Inc. / 32 10 x 1 mL Cartons; 14 50 x 1 mL Cartons | Class II | Terminated |
| D-1167-2014 | 03-03-2014 | Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10 | Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval. | McKesson Packaging Services / 1,557 Boxes | Class III | Terminated |
| D-0003-2015 | 02-26-2014 | All sterile drugs compounded between 2/21/14 and 2/24/14. | Lack of Assurance of Sterility: All compounded products. | New England Home Therapies, Inc / 87 Products | Class II | Terminated |
| D-1166-2014 | 02-26-2014 | Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43 Package NDCs: 0573-0164-33; 0573-0164-04; 0573-0164-20; 0573-0164-30; 0573-0164-40; 0573-0164-43; 0573-0164-45; 0573-0164-32; 0573-0164-41; 0573-0164-91; 0573-0164-05; 0573-0164-55; 0573-0164-21; 0573-0164-44; 0573-0164-14; 0573-0164-12; 0573-0164-49; 0573-0164-46; 0573-0164-65; 0573-0164-08; 0573-0164-09 | Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate. | Pfizer Us Pharmaceutical Group / 70,704 bottles | Class III | Terminated |
