Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1379-2014 | 01-24-2014 | Magic Slim capsules, supplied in 60 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine | MyNicNaxs, Inc. / unknown | Class I | Terminated |
| D-1375-2014 | 01-24-2014 | Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd) 400 mg, supplied in 40 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein | MyNicNaxs, Inc. / unknown | Class I | Terminated |
| D-1380-2014 | 01-24-2014 | Meizitang Strong Version Botanical Slimming, Soft Gel Capsules, 650 mg, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine | MyNicNaxs, Inc. / unknown | Class I | Terminated |
| D-1371-2014 | 01-24-2014 | REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC., Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein. | MyNicNaxs, Inc. / 100 boxes | Class I | Terminated |
| D-1372-2014 | 01-24-2014 | JIANFEIJINDAN Activity Girl Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine | MyNicNaxs, Inc. / unknown | Class I | Terminated |
| D-1378-2014 | 01-24-2014 | Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product from Globe All Wellness, LLC Hollywood, FL 33020, distributed by MyNicKnaxs, LLC Deltona, FL | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine | MyNicNaxs, Inc. / unknown | Class I | Terminated |
| D-1148-2014 | 01-22-2014 | Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11. Package NDCs: 63323-542-01; 63323-542-07; 63323-276-01; 63323-276-02; 63323-915-01; 63323-047-01; 63323-047-10; 63323-543-02; 63323-459-09; 63323-540-01; 63323-540-11; 63323-540-31; 63323-262-01 | Subpotent; 18 month time point | Fresenius Kabi USA, LLC / 161,650 vials | Class II | Terminated |
| D-1086-2014 | 01-16-2014 | Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90 Package NDCs: 63304-828-90; 63304-828-05; 63304-827-90; 63304-827-05; 63304-829-90; 63304-829-05; 63304-830-90; 63304-830-05 | Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg. | Ranbaxy Inc. / 64,626 bottles | Class II | Terminated |
| D-1041-2014 | 01-16-2014 | ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01074 9, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls. | The Mentholatum Co. / | Class II | Terminated |
| D-1039-2014 | 01-16-2014 | ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01096 1, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls. | The Mentholatum Co. / | Class II | Terminated |
| D-1038-2014 | 01-16-2014 | ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01086 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls. | The Mentholatum Co. / 94,080 units Total (432 units held in stock, quarantined) | Class II | Terminated |
| D-1037-2014 | 01-16-2014 | ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls. | The Mentholatum Co. / 59, 376 units Total (32,184 units held in stock, quarantined) | Class II | Terminated |
| D-1040-2014 | 01-16-2014 | ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness Reliever Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01099 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. | Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls. | The Mentholatum Co. / | Class II | Terminated |
| D-1053-2014 | 01-15-2014 | Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01. | Failed Tablet/Capsule Specifications; Product contains broken tablets. | Watson Laboratories Inc / 717 bottles | Class II | Terminated |
| D-1165-2014 | 01-14-2014 | Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001 | Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin. | Traxx International Corp / 30,800 Kg | Class II | Terminated |
| D-1084-2014 | 01-14-2014 | Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01 | Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification. | Mylan Pharmaceuticals Inc. / 138,970 bottles | Class II | Terminated |
| D-1312-2014 | 01-13-2014 | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 | Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. | Merck & Co Inc / 11,462 cartons | Class III | Terminated |
| D-1311-2014 | 01-13-2014 | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 | This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. | Merck & Co Inc / 36,493 cartons | Class III | Terminated |
| D-1309-2014 | 01-13-2014 | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 | This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. | Merck & Co Inc / 11,175 cartons | Class III | Terminated |
| D-1310-2014 | 01-13-2014 | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC 66582-321-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 | This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. | Merck & Co Inc / 20,259 cartons | Class III | Terminated |
| D-1327-2014 | 01-13-2014 | PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA | Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin | HUMAN SCIENCE FOUNDATION / 24,268 bottles | Class I | Terminated |
| D-1540-2014 | 01-10-2014 | DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02 Package NDCs: 0409-2344-01; 0409-2344-62; 0409-2344-02 | Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution. | Hospira Inc. / 123,900 vials | Class I | Terminated |
| D-1494-2014 | 01-10-2014 | Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002 and in 50 ml containers in the Therametics Complexion Repair Acne Treatment System Kit with a SKU number of CR1005; and in 30 ml containers in the Therametics Complexion Repair Acne Travel Kit with a SKU number of CR1007. | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / | Class II | Terminated |
| D-1495-2014 | 01-10-2014 | Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit with SKU numbers of CR1005 and CR1007, respectively. | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / | Class II | Terminated |
| D-1488-2014 | 01-10-2014 | Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020. | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / unknown | Class II | Terminated |
| D-1491-2014 | 01-10-2014 | Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068. | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / | Class II | Terminated |
| D-1493-2014 | 01-10-2014 | Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005 | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / | Class II | Terminated |
| D-1490-2014 | 01-10-2014 | Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002. | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / unknown | Class II | Terminated |
| D-1487-2014 | 01-10-2014 | Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026 | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / unknown | Class II | Terminated |
| D-1489-2014 | 01-10-2014 | Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008. | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / unknown | Class II | Terminated |
| D-1492-2014 | 01-10-2014 | Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019 | Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. | Dermamedics, L.L.C. / | Class II | Terminated |
| D-1035-2014 | 01-09-2014 | Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05 | Lack of Assurance of Sterility; potential leakage from administrative port. | Hospira Inc. / 15258 bags | Class II | Terminated |
| D-1335-2014 | 01-09-2014 | BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 500 1-ct blisters; 30 3-ct bottles, 4 12-ct bottles | Class I | Terminated |
| D-1339-2014 | 01-09-2014 | ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 57 boxes | Class I | Terminated |
| D-1338-2014 | 01-09-2014 | Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured For: BTQ Ski, Inc., Chicago, IL 60638 | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 59/1-ct blister pack, 97/12-ct bottles | Class I | Terminated |
| D-1337-2014 | 01-09-2014 | MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 49 blister packs | Class I | Terminated |
| D-1340-2014 | 01-09-2014 | XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 89 blister packs | Class I | Terminated |
| D-1334-2014 | 01-09-2014 | XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 175 blister packs | Class I | Terminated |
| D-1336-2014 | 01-09-2014 | SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY. | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. | Schindele Enterprises dba Midwest Wholesale / 2 blister packs | Class I | Terminated |
| D-1036-2014 | 01-09-2014 | Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59. Package NDCs: 0409-7620-13; 0409-7620-03; 0409-7620-49; 0409-7620-59; 0409-1005-01; 0409-1005-20; 0409-2222-01; 0409-2222-12 | Lack of Assurance of Sterility; potential leakage from administrative port. | Hospira Inc. / 27780 bags | Class II | Terminated |
| D-1146-2014 | 01-03-2014 | a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe Road, Matthews, NC 28105 USA c) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 14 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 d) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 28 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 e) Equate Lansoprazole Delayed-Release Capsules USP, 15 mg Acid Reducer, 14 capsules per Bottle, and 28 capsules per bottle (Twin Pack)Distributed by Wal-mart Stores Inc. Bentonville, AR 72716 f) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 42 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 | Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules. | Dr. Reddy's Laboratories, Inc. / 58,656 Bottles | Class II | Terminated |
| D-745-2014 | 01-02-2014 | Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-84 Package NDCs: 0069-3150-84; 0069-3150-83 | Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant. | Pfizer Inc. / 101,681 Vials | Class III | Terminated |
| 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; 0409-1511-97; 0409-1511-98; 0409-0501-97; 0409-0501-98; 0409-0010-97; 0409-0010-98 | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
