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-1304-2014 | 12-27-2013 | Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005313, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703 . | Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. | Mangiacotti / N/A | Class II | Terminated |
| D-1303-2014 | 12-27-2013 | Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, UPC 870678005306, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703. | Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. | Mangiacotti / N/A | Class II | Terminated |
| D-1305-2014 | 12-27-2013 | Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005320, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703. | Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. | Mangiacotti / N/A | Class II | Terminated |
| D-1308-2014 | 12-27-2013 | Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005351, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703. | Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. | Mangiacotti / N/A | Class II | Terminated |
| D-1306-2014 | 12-27-2013 | Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703. | Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. | Mangiacotti / N/A | Class II | Terminated |
| D-1307-2014 | 12-27-2013 | Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005344, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703. | Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens. | Mangiacotti / N/A | Class II | Terminated |
| D-1351-2014 | 12-23-2013 | Burn 7 Capsules, supplied in 30 capsules bottle | Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement | Deseo Rebajar / 120 bottles | Class I | Terminated |
| D-1278-2014 | 12-23-2013 | Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05. Package NDCs: 0409-2066-10; 0409-2066-05 | Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution. | Hospira Inc. / 68,350 vials | Class I | Terminated |
| D-397-2014 | 12-23-2013 | Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05. | Presence of Foreign Substance; metal particulates were visually observed in the tablets. | Watson Laboratories Inc / 4,439 bottles | Class II | Terminated |
| D-1082-2014 | 12-20-2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6. Package NDCs: 0591-0397-60; 0591-0397-19; 0591-0398-60 | Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. | Watson Laboratories, Inc.-(Actavis) - Florida / 5987 bottles | Class II | Terminated |
| D-1359-2014 | 12-20-2013 | CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18 | Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label. | Carefusion 2200 Inc / 2,443,500 scrub brushes | Class II | Terminated |
| D-1360-2014 | 12-20-2013 | CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15. | Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label. | Carefusion 2200 Inc / 1,662,000 Surgical Scrub Brushes | Class II | Terminated |
| D-1563-2014 | 12-19-2013 | MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX | Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis | Abrams Royal Pharamacy / 74 | Class I | Terminated |
| D-1564-2014 | 12-19-2013 | All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX | Lack of Assurance of Sterility | Abrams Royal Pharamacy / N/A | Class II | Terminated |
| D-1075-2014 | 12-18-2013 | Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0555-89 (carton) and 00182-0555-00 (single blister). | Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life. | Teva Pharmaceuticals USA / 112,800 tablets | Class II | Terminated |
| D-1074-2014 | 12-18-2013 | Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (single blister). | Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life. | Teva Pharmaceuticals USA / 1,249,700 tablets | Class II | Terminated |
| D-394-2014 | 12-16-2013 | Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL). | Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone. | Qualitest Pharmaceuticals / 438,055 bottles | Class III | Terminated |
| D-1083-2014 | 12-16-2013 | VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03. | Failed Stability Testing: This product is below specification for preservative content. | Bracco Diagnostics Inc / 54,648 bottles | Class III | Terminated |
| D-1079-2014 | 12-13-2013 | Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC Middlesex, NJ 08846, NDC 64720-128-10 | Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point. | Corepharma LLC / 174,888 Bottles | Class II | Terminated |
| D-1080-2014 | 12-13-2013 | Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratories Limited Bachepalli -500 090 INDIA NDC 55111-467-01 Package NDCs: 55111-466-30; 55111-466-60; 55111-466-01; 55111-466-05; 55111-466-79; 55111-466-78; 55111-467-30; 55111-467-60; 55111-467-01; 55111-467-05; 55111-467-79; 55111-467-78 | Failed Dissolution Specification; 12-Month stability interval. | Dr. Reddy's Laboratories, Inc. / 8,592 bottles | Class II | Terminated |
| D-1033-2014 | 12-12-2013 | Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, 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: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution. | Hospira Inc. / 126,425 vials | Class II | Terminated |
| D-1218-2014 | 12-12-2013 | Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. | Zions RX Formulations Services LLC dba RX Formuations Serv. / 60 units | Class II | Terminated |
| D-1215-2014 | 12-12-2013 | Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. | Zions RX Formulations Services LLC dba RX Formuations Serv. / 95 Vials | Class II | Terminated |
| D-1216-2014 | 12-12-2013 | Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. | Zions RX Formulations Services LLC dba RX Formuations Serv. / 1,495 Bags | Class II | Terminated |
| D-1214-2014 | 12-12-2013 | Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. | Zions RX Formulations Services LLC dba RX Formuations Serv. / 861 Bags | Class II | Terminated |
| D-1219-2014 | 12-12-2013 | Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. | Zions RX Formulations Services LLC dba RX Formuations Serv. / 38 units | Class II | Terminated |
| D-1213-2014 | 12-12-2013 | Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ, 85205. | Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe. | Zions RX Formulations Services LLC dba RX Formuations Serv. / 450 Vials | Class I | Terminated |
| D-1217-2014 | 12-12-2013 | Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205 | Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm. | Zions RX Formulations Services LLC dba RX Formuations Serv. / 610 units | Class II | Terminated |
| D-1030-2014 | 12-11-2013 | HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01. Package NDCs: 10702-010-01; 10702-010-50; 10702-010-10; 10702-011-01; 10702-011-50; 10702-011-10; 10702-012-01; 10702-012-50; 10702-012-10 | Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. | KVK-Tech, Inc. / 14664 bottles | Class II | Terminated |
| D-1032-2014 | 12-11-2013 | HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10. Package NDCs: 10702-010-01; 10702-010-50; 10702-010-10; 10702-011-01; 10702-011-50; 10702-011-10; 10702-012-01; 10702-012-50; 10702-012-10 | Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. | KVK-Tech, Inc. / 104551 bottles | Class II | Terminated |
| D-1031-2014 | 12-11-2013 | HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10. Package NDCs: 10702-010-01; 10702-010-50; 10702-010-10; 10702-011-01; 10702-011-50; 10702-011-10; 10702-012-01; 10702-012-50; 10702-012-10 | Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. | KVK-Tech, Inc. / 249,096 bottles | Class II | Terminated |
| D-1222-2014 | 12-10-2013 | Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing). | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug. | Slim Beauty USA / 3 bottles | Class I | Terminated |
| D-1220-2014 | 12-10-2013 | Dr. Ming's Chinese Capsule (Ginger 50 mg, Camellia Sinensis 50 mg, Malus Domestica 50 mg, Propetary Blend 300 mg Cynara Scolymus, Hoodia, Siruline, Chitosan, 60-count bottles, Distributed by Natural Products, Doral, FL 33178. | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug. | Slim Beauty USA / 4 bottles | Class I | Terminated |
| D-1221-2014 | 12-10-2013 | Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Nature Substance), 60-count bottles. | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug. | Slim Beauty USA / 2 bottles | Class I | Terminated |
| D-1085-2014 | 12-09-2013 | Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose Delivery System containing 2 mL Sterile Water for Injection, USP per carton (NDC 52544-188-76), 11.25 mg, Rx Only, Dist. By: Watson Pharma, Inc., Morristown, NJ 07962, Mfd. by: Debio RP, CH-1920 Martigny, Switzerland. | Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg. | Actavis Inc / 99 cartons | Class II | Terminated |
| D-379-2014 | 12-06-2013 | FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11 | Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point | Fresenius Kabi USA, LLC / 215,340 vials | Class III | Terminated |
| D-382-2014 | 12-04-2013 | Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9. | Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves. | Teva Pharmaceuticals USA / 379,463 inhalers | Class III | Terminated |
| D-407-2014 | 11-27-2013 | 0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00. Package NDCs: 0264-7800-00; 0264-7800-10; 0264-7800-20; 0264-7802-00; 0264-7802-10 | Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter). | B. Braun Medical Inc / 19,572 bags | Class II | Terminated |
| D-1042-2014 | 11-27-2013 | Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02. | Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications. | Wockhardt Usa Inc. / 1129 bottles | Class II | Terminated |
| D-1048-2014 | 11-26-2013 | Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Aqueous solution. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic. Sold under the following brands: a) Good Neighbor Pharmacy NDC 24385-593-46 , b) Quality Choice, NDC 63868-0488-02; c) Select Brand NDC 15127-885-59; d) Premier Value UPC 4098602556; e) Rite Aid Pharmacy UPC 011822576871; f) TopCare UPC 3680033436; g) Vida Mia UPC 847717060718; h) Humco 2 fl. oz NDC 0395-1637-92 i) Humco 3 fl. oz. NCD 0395-1637-93 ; 2 fl OZ (59 mL) and 3 FL OZ (90 mL) bottles, HUMCO, Texarkana, TX 75501. | Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp. | Humco Holding Group, Inc / | Class II | Terminated |
| D-396-2014 | 11-26-2013 | Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98 | Failed Tablet/Capsule Specifications: There is a potential for broken tablets. | Teva Pharmaceuticals USA / 10,512 bottles | Class II | Terminated |
| D-1078-2014 | 11-22-2013 | Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY DOLGENCORP LLC, GOODLETTSVILLE, TN 37072 | Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing | Faria Limited LLC dba Sheffield Pharmaceuticals / 26424 | Class II | Terminated |
| D-1077-2014 | 11-22-2013 | FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105 | Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing | Faria Limited LLC dba Sheffield Pharmaceuticals / 147566 | Class II | Terminated |
| D-390-2014 | 11-22-2013 | Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals Drugs LTD, Pondicherry, INDIA. Repacked and Distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. 90 count bottle: NDC: 54868-0816-8, 60 count bottle: NDC: 54868-0816-4, 30 count bottle: NDC: 54686-0816-3. | Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing. | Physicians Total Care, Inc. / 3,000 tablets | Class II | Terminated |
| D-1076-2014 | 11-22-2013 | Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320 Package NDCs: 11527-162-51; 11527-162-30; 11527-162-55; 11527-162-47; 11527-162-27; 11527-163-55 | Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing | Faria Limited LLC dba Sheffield Pharmaceuticals / 332508 | Class II | Terminated |
| D-1163-2014 | 11-21-2013 | 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag | Baxter Healthcare Corp. / 716,544 containers | Class I | Terminated |
| D-1267-2014 | 11-21-2013 | Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3193-11 Package NDCs: 0264-3193-11; 0264-3195-11 | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. | B. Braun Medical Inc / 22,248 units | Class I | Terminated |
| D-1162-2014 | 11-21-2013 | 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38. Package NDCs: 0338-0017-10; 0338-0017-41; 0338-0017-11; 0338-0017-31; 0338-0017-48; 0338-0017-18; 0338-0017-38; 0338-0017-02; 0338-0017-03; 0338-0017-04; 0338-0023-02; 0338-0023-03; 0338-0023-04 | Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag | Baxter Healthcare Corp. / 105,216 containers | Class I | Terminated |
| D-1268-2014 | 11-21-2013 | Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3103-11 Package NDCs: 0264-3103-11; 0264-3105-11; 0264-3107-11 | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. | B. Braun Medical Inc / 136,392 units | Class I | Terminated |
| D-1269-2014 | 11-21-2013 | Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical Inc., Irvine CA 92614, NDC 0264-3105-11 Package NDCs: 0264-3103-11; 0264-3105-11; 0264-3107-11 | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. | B. Braun Medical Inc / 42,576 units | Class I | Terminated |
| D-1265-2014 | 11-21-2013 | 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31 Package NDCs: 0264-1800-36; 0264-1800-31; 0264-1800-32 | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. | B. Braun Medical Inc / 53,592 units | Class I | Terminated |
| D-1275-2014 | 11-21-2013 | Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311 | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. | B. Braun Medical Inc / 5,592 units | Class I | Terminated |
| D-1272-2014 | 11-21-2013 | 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, Sterile, Single Dose Container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-3200-55 | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. | B. Braun Medical Inc / 18,288 units | Class I | Terminated |
| D-1274-2014 | 11-21-2013 | ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07 | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. | B. Braun Medical Inc / 18,090 units | Class I | Terminated |
| D-1266-2014 | 11-21-2013 | Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895 | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. | B. Braun Medical Inc / 32,376 units | Class I | Terminated |
| D-1271-2014 | 11-21-2013 | 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55 | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. | B. Braun Medical Inc / 4614 units | Class I | Terminated |
| D-1270-2014 | 11-21-2013 | 0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55 | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. | B. Braun Medical Inc / 1302 units | Class I | Terminated |
| D-1273-2014 | 11-21-2013 | TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55 | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. | B. Braun Medical Inc / 17,544 units | Class I | Terminated |
| D-1264-2014 | 11-21-2013 | Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11 Package NDCs: 0264-3123-11; 0264-3125-11 | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. | B. Braun Medical Inc / 22,584 units | Class I | Terminated |
| D-1346-2014 | 11-19-2013 | NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466 | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs. | Tendex / unknown | Class I | Terminated |
| D-1364-2014 | 11-19-2013 | vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148. | Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules | Vitality Research Labs LLC / 11,523 bottles of lot K58Q; 54,255 bottles of lot F50Q | Class I | Terminated |
| D-1345-2014 | 11-19-2013 | P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466 | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs. | Tendex / unknown | Class I | Terminated |
| D-1248-2014 | 11-18-2013 | RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309 | Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil. | Fossil Fuel Products, LLC / 50,300 capsules | Class I | Terminated |
| D-1046-2014 | 11-18-2013 | MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2. | Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved | SS Wholesale Inc. dba Jobbers Wholesale / 2,395 blister packs total for all products | Class I | Terminated |
| D-1045-2014 | 11-18-2013 | Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3. | Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved by | SS Wholesale Inc. dba Jobbers Wholesale / 2,395 blister packs total for all products | Class I | Terminated |
| D-1047-2014 | 11-18-2013 | eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6. | Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved b | SS Wholesale Inc. dba Jobbers Wholesale / 2,395 blister packs total for all products | Class I | Terminated |
| D-1044-2014 | 11-18-2013 | KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9. Package NDCs: 0168-0099-15; 0168-0099-30; 0168-0099-60 | Failed Impurities/Degradation Specifications: Out-of-Specification degradant results. | Fougera Pharmaceuticals Inc. / 31,122 tubes | Class III | Terminated |
| D-1057-2014 | 11-18-2013 | 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02 Package NDCs: 0338-1047-02; 0338-1049-02; 0338-1051-02 | Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper. | Baxter Healthcare Corp. / 49,932 glass containers | Class I | Terminated |
| D-1160-2014 | 11-18-2013 | Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04. Package NDCs: 0338-1133-03; 0338-1089-04; 0338-1134-03; 0338-1091-04; 0338-1137-03; 0338-1099-04; 0338-1138-03; 0338-1101-04; 0338-0198-01; 0338-0198-06; 0338-0188-01; 0338-0188-06; 0338-0194-01; 0338-0194-04; 0338-0180-01; 0338-0180-06; 0338-0184-01; 0338-0184-04; 0338-7001-01; 0338-7001-06; 0338-7003-01; 0338-7003-04; 0338-7005-01; 0338-7005-06; 0338-7007-01; 0338-7007-04; 0338-7009-01; 0338-7009-06; 0338-7011-01; 0338-7011-04; 0338-7013-01; 0338-7013-06; 0338-7015-01; 0338-7015-04 | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. / 7,388 bags | Class I | Terminated |
| D-1159-2014 | 11-18-2013 | Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04. Package NDCs: 0338-1142-03; 0338-1144-03; 0338-1113-04; 0338-1145-03; 0338-1115-04; 0338-1147-03; 0338-1123-04; 0338-1125-04; 0338-1148-03; 0338-0202-01; 0338-0202-06; 0338-0206-01; 0338-0206-04; 0338-0210-01; 0338-0210-06; 0338-0214-01; 0338-0214-04; 0338-7020-01; 0338-7020-06; 0338-7022-01; 0338-7022-06; 0338-7024-01; 0338-7024-04; 0338-7026-01; 0338-7026-06; 0338-7028-01; 0338-7028-04; 0338-7030-01; 0338-7030-06; 0338-7032-01; 0338-7032-04; 0338-7034-01; 0338-7034-06; 0338-7036-01; 0338-7036-04 | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. / 7,068 bags | Class I | Terminated |
| D-1158-2014 | 11-18-2013 | Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04. Package NDCs: 0338-1142-03; 0338-1144-03; 0338-1113-04; 0338-1145-03; 0338-1115-04; 0338-1147-03; 0338-1123-04; 0338-1125-04; 0338-1148-03; 0338-0202-01; 0338-0202-06; 0338-0206-01; 0338-0206-04; 0338-0210-01; 0338-0210-06; 0338-0214-01; 0338-0214-04; 0338-7020-01; 0338-7020-06; 0338-7022-01; 0338-7022-06; 0338-7024-01; 0338-7024-04; 0338-7026-01; 0338-7026-06; 0338-7028-01; 0338-7028-04; 0338-7030-01; 0338-7030-06; 0338-7032-01; 0338-7032-04; 0338-7034-01; 0338-7034-06; 0338-7036-01; 0338-7036-04 | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. / 14,574 bags | Class I | Terminated |
| D-384-2014 | 11-16-2013 | Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691 | Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination. | Tower Pharmacy and Compounding / 2 Bottles | Class II | Terminated |
| D-1043-2014 | 11-15-2013 | BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880 Package NDCs: 0591-3331-30; 0591-3331-19; 0591-3331-05 | Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. | Actavis Inc / 139,944 bottles | Class III | Terminated |
| D-747-2014 | 11-14-2013 | Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95. | Failed Stability Specifications: this product is below specification for preservative content. | Teva Pharmaceuticals USA, Inc. / 234,242 bottles | Class III | Terminated |
| D-1252-2014 | 11-13-2013 | Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional only, not for resale, MD Custom Rx, 19035 W Capitol Dr Ste 105, Brookfield, WI 53045. | Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis. | Brookfield Prescription Center Inc / 25 Vials | Class I | Terminated |
| D-1065-2014 | 11-13-2013 | Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05. | Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. | Forest Pharmaceuticals Inc / 111,384 sample packs | Class III | Terminated |
| D-1063-2014 | 11-13-2013 | Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33 | Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. | Forest Pharmaceuticals Inc / 156 bottles | Class III | Terminated |
| D-1064-2014 | 11-13-2013 | Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29. | Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing. | Forest Pharmaceuticals Inc / 3,950 packs | Class III | Terminated |
| D-368-2014 | 11-12-2013 | 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. NDC: 0338-0644-06. Package NDCs: 0338-0644-03; 0338-0644-04; 0338-0644-06 | Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured | Baxter Healthcare Corp. / 14,622 bags | Class II | Terminated |
| D-016-2014 | 11-08-2013 | PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India Package NDCs: 63323-763-05; 63323-763-16; 63323-763-50 | Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections. | Fresenius Kabi USA, LLC / 71,129 vials | Class III | Terminated |
| D-1061-2014 | 11-08-2013 | Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56 | Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets. | Teva Pharmaceuticals USA, Inc. / 7,020 bottles | Class II | Terminated |
| D-1277-2014 | 11-07-2013 | Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com. | Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement. | Deseo Rebajar / 1,146 bottles | Class I | Terminated |
| D-367-2014 | 11-07-2013 | Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10. | Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing | West-Ward Pharmaceutical Corp. / 20,534 bottles | Class II | Terminated |
| D-388-2014 | 11-06-2013 | Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Singapore, NDC 0781-3173-07. | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. | GlaxoSmithKline, LLC. / 9,743 cartridges | Class II | Terminated |
| D-1087-2014 | 11-06-2013 | Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton) | Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification. | Actavis Elizabeth LLC / 13,608 bottles | Class II | Terminated |
| D-366-2014 | 11-06-2013 | Carbon Dioxide, USP, Medical Gas, Rx only, Non Flammable Gas 2, in 50 lbs steel cylinders, Distributed by AIRGAS USA, LLC Radnor, PA | Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube indicating liquid withdrawal and shipped as a gas withdrawal cylinder. | Airgas Medical Services / 264 cylinders | Class II | Terminated |
| D-341-2014 | 11-06-2013 | Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05 Package NDCs: 0185-0128-05; 0185-0128-01; 0185-0129-05; 0185-0129-01; 0185-0130-05; 0185-0130-01 | Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions. | Sandoz Inc / 11,496 bottles (100 count) and 62 bottles (500 count) | Class III | Terminated |
| D-387-2014 | 11-06-2013 | Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1 carrying case, Rx only, 6 mg, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in Singapore, NDC 0173-0479-00 Package NDCs: 0173-0739-00; 0173-0739-02; 0173-0479-00; 0173-0478-00 | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. | GlaxoSmithKline, LLC. / 10,469 Systems | Class II | Terminated |
| D-746-2014 | 11-05-2013 | sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 07977 -- MADE IN INDIA --- NDC 59762-4960-1 | Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life | Greenstone LLC / 585,096 bottles | Class II | Terminated |
| D-1050-2014 | 11-04-2013 | Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabolicnutrition.com | Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug | IQ Formulations, LLC / | Class I | Terminated |
| D-1059-2014 | 11-04-2013 | Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2 | Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval | Greenstone Llc / 22,529 bottles | Class III | Terminated |
| D-1058-2014 | 11-04-2013 | Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66 | Failed Dissolution Specification; 8 hr stability timepoint | Pfizer Inc. / 14,357 bottles | Class III | Terminated |
| D-1049-2014 | 11-04-2013 | Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6. Package NDCs: 25682-001-01 | Presence of Particulate Matter: Failed the appearance test for the presence of visible particles. | Alexion Pharmaceuticals, Inc. / 21,661 vials | Class I | Terminated |
| D-005-2014 | 11-01-2013 | Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 13733 31403 9; c) Rite Aid infants' fever reducer & pain reliever oral suspension, Distributed By: Rite Aid, 30 hunter Lane, Camp Hill, PA 17011, UPC 0 11822 35341 0; d) Walgreens infants' Dye-Free Pain & Fever acetaminophen suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0766-16, UPC 3 11917 13223 5; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-766-16, UPC 0 41260 35830 2 Package NDCs: 36800-766-16; 41250-766-16; 41250-766-10; 30142-766-16; 0363-0766-16 | Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. | L. Perrigo Co. / 27,504 bottles | Class II | Terminated |
| D-004-2014 | 11-01-2013 | Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, Ohio 43017, NDC 37205-577-16, UPC 0 96295 12095 0; b) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0161-16, UPC 3 11917 13221 1; c) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-161-16, UPC 0 41260 35831 9; d) H-E-B Pain & Fever acetaminophen suspension Infants', Made With Pride & Care For H-E-B, San Antonio, TX 78204, NDC 37808-161-16, UPC 0 41220 88066 9; e) Babies R Us Infants' Pain & Fever acetaminophen suspension, Distributed by Toys R Us, Inc., Wayne, NJ 07470, NDC 51334-161-16, UPC 7 17851 20094 6; f) healthy accents infants' pain & fever acetaminophen suspension liquid, Distributed By: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074, NDC 55316-161-16, UPC 7 25439 95814 1; g) Health Mart Pharmacy infants' pain & fever acetaminophen suspension liquid, Distributed by McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0002-1, UPC 0 52569 13248 7 Package NDCs: 37808-161-16; 37205-577-16; 0363-0161-16; 30142-161-16; 51334-161-16; 55316-161-16; 62011-0002-1 | Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. | L. Perrigo Co. / 35,136 bottles | Class II | Terminated |
| D-003-2014 | 11-01-2013 | Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe in a carton and sold under the following: a) equaling infants' pain & fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by SUPERVALU Inc., Eden Prairie, MN 55344, NDC 41163-590-16, UPC 0 41163 48657 7; b) Up & Up dye free infants' pain and fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-590-16, UPC 3 70030 62529 1; c) equate Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-590-16, UPC 6 81131 00185 4; d) Meijer Infants' Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, NDC 41250-590-16, UPC 7 13733 31376 6; e) Walgreens infants' Dye-Free Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0590-16, UPC 3 11917 13222 8; f) Kroger Infants' Pain & Fever suspension liquid, 4 FL OZ (118 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-26, UPC 0 41260 36738 0; g) Kroger Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-16, UPC 0 41260 35829 6; h) Publix Infants' painrelief acetaminophen suspension liquid, 2 FL OZ (59 mL), Distributed By Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 55062-590-16, UPC 0 41415 39573 2; i) CareOne Infants' Dye-Free Pain Relief acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed By Foodhold U.S.A., LLC, Landover, MD 20785, NDC 41520-590-16, UPC 3 41520 31006 5; j) Harmon FaceValues Infants' Pain & Fever acetaminophen suspension Liquid, 2 FL OZ (59 mL), Distributed by Harmon Stores, Inc., 650 Liberty Ave., Union, NJ 07083 USA, UPC 3 70030 51018 4 Package NDCs: 41250-590-16; 41250-590-10; 30142-590-16; 30142-590-26; 41163-590-16; 11673-590-16; 49035-590-16; 0363-0590-16; 55062-590-16; 41520-590-16 | Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. | L. Perrigo Co. / 143,892 bottles | Class II | Terminated |
| D-006-2014 | 11-01-2013 | Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) equate Infants' Pain & Fever acetaminophen suspension liquid, Distributed by: Wal-Mart Stores, Inc., Bentonville, AZ 72716, NDC 49035-946-16, UPC 0 78742 09060 3; b) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-576-16, UPC 0 96295 12093 6; c) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-946-16, UPC 0 36800 34645 1; d) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0946-16, UPC 3 11917 13225 9; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-946-16, UPC 0 41260 35832 6 Package NDCs: 49035-946-10; 49035-946-16; 36800-946-16; 36800-946-10; 37205-576-16; 0363-0946-16; 30142-946-16 | Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. | L. Perrigo Co. / 108,828 bottles | Class II | Terminated |
| D-1110-2014 | 11-01-2013 | Ethanol 20% ophthal. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1126-2014 | 11-01-2013 | Papaverine 1nj 30mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
| D-1137-2014 | 11-01-2013 | Testosterone Cypionate 100mg/ml | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Natures Pharmacy & Compounding Center / | Class II | Terminated |
