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-0659-2016 | 12-31-2015 | Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540 | Failed Impurities/Degradation Specifications; 9 month stability timepoint | Sandoz Inc / 277,267 bottles | Class III | Terminated |
| D-0777-2016 | 12-31-2015 | NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61 | Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration | Pharmedium Services, LLC / 6,816 bags | Class III | Terminated |
| D-0778-2016 | 12-31-2015 | NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61 | Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration | Pharmedium Services, LLC / | Class III | Terminated |
| D-0733-2016 | 12-29-2015 | Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023 | Lack of assurance of sterility | TexasStar Pharmacy / 700 mL (7 vials of 100 mL) | Class II | Terminated |
| D-0917-2017 | 12-29-2015 | Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014 | Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture. | Complete Pharmacy and Medical Solutions LLC / 1890 syringes | Class I | Ongoing |
| D-0569-2016 | 12-24-2015 | Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614 | Lack of Assurance of Sterility | Amerita Specialty Infusion Services / 1 syringe | Class II | Terminated |
| D-0653-2016 | 12-24-2015 | Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10. Package NDCs: 33342-031-10; 33342-031-15; 33342-031-06; 33342-031-12; 33342-032-10; 33342-032-15; 33342-032-06; 33342-032-12; 33342-033-10; 33342-033-15; 33342-033-06; 33342-033-12; 33342-034-10; 33342-034-15; 33342-034-06; 33342-034-12; 33342-035-10; 33342-035-15; 33342-035-06; 33342-035-12 | Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet. | Macleods Pharma Usa Inc / N/A | Class II | Terminated |
| D-0570-2016 | 12-24-2015 | IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614 | Lack of Assurance of Sterility | Amerita Specialty Infusion Services / 1 syringe | Class II | Terminated |
| D-0020-2017 | 12-23-2015 | Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein | Bee Xtreme / 732 bottles | Class I | Terminated |
| D-0019-2017 | 12-23-2015 | La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein | Bee Xtreme / 589 bottles | Class I | Terminated |
| D-0021-2017 | 12-23-2015 | Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein | Bee Xtreme / 13 bottles | Class I | Terminated |
| D-0667-2016 | 12-23-2015 | APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7. | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug. | Nuway Distributors, LLC / 100,000 blister cards | Class I | Ongoing |
| D-0578-2016 | 12-22-2015 | Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Shingles Pain & Ulceration Relief Topical Homeopathic Spray, NDC 50845-0215-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Shingles Pain & Ulceration Relief, homeopathic spray, UPC 8 18692 00875 0, NDC 43845-0044-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA | Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count | Grato Holdings, Inc. / 371 bottles | Class II | Terminated |
| D-0576-2016 | 12-22-2015 | Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0132-1, Dist. by Energique, Inc. Woodbine, IA 51579; ALSO LABELED AS --- Liddell Laboratories, Muscle/Tendon Pain & Stress Relief, Topical Homeopathic Spray, NDC 50845-0219-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Muscle/Tendon Pain & Stress Relief, homeopathic spray, UPC 8 18692 00870 5, NDC 43846-0043, Dist. by Peaceful Mountain, Inc. Woodbine, IA | Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count | Grato Holdings, Inc. / 201 bottles | Class II | Terminated |
| D-0579-2016 | 12-22-2015 | Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Headache Pain & Sinus Pressure Relief, Topical Homeopathic Spray, NDC 50845-0217-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Headache Pain & Sinus Pressure Relief, homeopathic spray, UPC 8 18692 00885 9, NDC 43846-0041-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA | Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count | Grato Holdings, Inc. / 90 bottles | Class II | Terminated |
| D-0580-2016 | 12-22-2015 | Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, First Aid Pain & Trauma Relief, Topical Homeopathic Spray, NDC 50845-0216-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, First Aid Pain & Trauma Relief, homeopathic spray, UPC 8 18692 00895 8, NDC 43846-0045-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA | Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count | Grato Holdings, Inc. / 118 bottles | Class II | Terminated |
| D-0575-2016 | 12-22-2015 | Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, skin irritant & healing support, homeopathic spray, UPC 8 18692 00880 4, NDC 43846-0046-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA | Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count | Grato Holdings, Inc. / 118 bottles | Class II | Terminated |
| D-0577-2016 | 12-22-2015 | Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Joint Pain & Stiffness Relief, Topical Homeopathic Spray, NDC 50845-0218-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Joint Pain & Stiffness Relief, homeopathic spray, UPC 8 18692 00890 3, NDC 43846-0042-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA | Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count | Grato Holdings, Inc. / 224 bottles | Class II | Terminated |
| D-0732-2016 | 12-21-2015 | Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89 Package NDCs: 0093-7473-06; 0093-7474-89 | Failed Dissolution Specifications: low test results at the 18 month time-point | Teva North America / 1,895 bottles | Class II | Terminated |
| D-1439-2016 | 12-21-2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 2088 boxes | Class II | Terminated |
| D-1438-2016 | 12-21-2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 7850 boxes | Class II | Terminated |
| D-1440-2016 | 12-21-2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 12285 boxes | Class II | Terminated |
| D-0568-2016 | 12-18-2015 | Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01 | Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg. | National Vitamin Co Inc / 29,827 bottles | Class III | Terminated |
| D-0801-2016 | 12-17-2015 | VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305 | Defective Delivery System: Product may contain leaking capsules. | Virtus Pharmaceuticals, Llc / 688 bottles ( 20,640 softgel capsules) | Class III | Terminated |
| D-0809-2016 | 12-17-2015 | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51 | Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing. | Bio-pharm, Inc. / 103,664 Bottles | Class III | Terminated |
| D-1142-2016 | 12-15-2015 | Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104 | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / 79 bottles | Class I | Terminated |
| D-1140-2016 | 12-15-2015 | EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E. Atlantic Blvd, Pompano Beach, Florida, 33062 WWW.BEEEXTREMELYAMAZED.COM | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1139-2016 | 12-15-2015 | Asset extreme+PLUS Capsules, 500 mg, 30-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com www.allnaturalbeelievers.com | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1150-2016 | 12-15-2015 | XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1143-2016 | 12-15-2015 | La' Trim Plus Capsules, 350 mg, 60-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando, FL 32801 (407) 930-4043 | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1149-2016 | 12-15-2015 | XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1147-2016 | 12-15-2015 | SLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-0571-2016 | 12-15-2015 | Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60 | Super-Potent Drug: Out of Specification Assay test results were reported for stability samples. | Morton Grove Pharmaceuticals, Inc. / 39,187 bottles | Class III | Terminated |
| D-1144-2016 | 12-15-2015 | Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando FL 32801 (407)930-4043 | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / 581 bottles | Class I | Terminated |
| D-1146-2016 | 12-15-2015 | SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceuticals Ltd. MUMBAI-400-030 Manufactured in India by: HAB Pharmaceuticals & Research Limited 10-Pharma City, SIDCUL, Selaqui, Dehradun, 248 197 | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1148-2016 | 12-15-2015 | Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu Tang Success, LLC Trexlertown, PA 18087, USA www.zixiutangsuccess.com | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1138-2016 | 12-15-2015 | Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1151-2016 | 12-15-2015 | ZI XIU TANG BEAUTY FACE & FIGURE Capsules, 250 mg, 60-count bottles | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1141-2016 | 12-15-2015 | Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1145-2016 | 12-15-2015 | Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. #392 Columbus, IN 47203 | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / 1,104 bottles | Class I | Terminated |
| D-0958-2016 | 12-15-2015 | Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06 Package NDCs: 0338-0719-06 | Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product. | Baxter Healthcare Corp. / 28,080 VIAFLEX Plastic Containers | Class I | Terminated |
| D-0957-2016 | 12-15-2015 | 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02 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: Confirmed customer compliants of finding an insect floating in the primary container of each product. | Baxter Healthcare Corp. / 255,852 VIAFLEX Plastic Containers | Class I | Terminated |
| D-0959-2016 | 12-11-2015 | FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs. | Reesna, Inc / 26,250 capsules | Class I | Terminated |
| D-0960-2016 | 12-11-2015 | FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs. | Reesna, Inc / 7,250 capsules | Class I | Terminated |
| D-0882-2016 | 12-09-2015 | Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010 | Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac. | Lucy's Weight Loss (dba. Waisted With Lucy) / Unknown | Class I | Terminated |
| D-0883-2016 | 12-09-2015 | Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010 | Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac. | Lucy's Weight Loss (dba. Waisted With Lucy) / Unknown | Class I | Terminated |
| D-0799-2016 | 12-08-2015 | Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1 Package NDCs: 58468-0160-1; 58468-0160-2 | Labeling: Incorrect or Missing Lot and/or Exp Date | Genzyme Corporation / 24 vials | Class III | Terminated |
| D-0650-2017 | 12-07-2015 | Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09 Package NDCs: 68180-556-09; 68180-557-09; 68180-557-03; 68180-558-09; 68180-558-03; 68180-554-09; 68180-554-03; 68180-559-03; 68180-559-09 | Failed Impurities/Degradation Specifications; Impurity A | Lupin Pharmaceuticals Inc. / 15,168 bottes | Class III | Terminated |
| D-0519-2016 | 12-03-2015 | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20 Package NDCs: 0173-0682-20; 0173-0682-24 | Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life. | GlaxoSmithKline, LLC / 128,704 Inhalers | Class II | Terminated |
| D-0860-2016 | 12-03-2015 | LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com | Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug. | Lipo Escultura Corp. / unknown | Class I | Terminated |
| D-0520-2016 | 12-02-2015 | Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017. Package NDCs: 0025-2752-31; 0025-2762-31; 0025-2732-31; 0025-2742-31; 0025-2742-51 | Failed Dissolution Specification | Pfizer Inc. / a) 4005 bottles, b) 104 bottles | Class III | Terminated |
| D-0779-2016 | 11-29-2015 | Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01 | cGMP Deviations; trailer may not have met GMP requirements prior to filling | AGA Gas Inc / 1,500 gallons | Class II | Terminated |
| D-0510-2016 | 11-25-2015 | MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Golden State Medical Supply Inc. / a) 737 Bottles; b) 3863 Bottles | Class III | Terminated |
| D-0509-2016 | 11-25-2015 | MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10. | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Golden State Medical Supply Inc. / 1136 Bottles | Class III | Terminated |
| D-0909-2016 | 11-23-2015 | SUPER HERBS 350 mg, 30 capsules per bottle. | Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein. | Super Herbs / 9 bottles | Class I | Terminated |
| D-0773-2016 | 11-19-2015 | NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL | Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles. | Teva Pharmaceuticals USA / 576 bottles | Class III | Terminated |
| D-0510-2019 | 11-12-2015 | tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G, Distributed by: Tubby Todd Bath Co. Vista, CA 920, (619) 894-6560. | Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold. | Mariposa Labs LLC / 1654 jars | Class II | Terminated |
| D-0566-2016 | 11-12-2015 | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0. Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing. | Teva Pharmaceuticals USA / 9,717 bottles | Class II | Terminated |
| D-0517-2016 | 11-11-2015 | Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0222-57 | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. | RemedyRepack Inc. / 4 Vials | Class II | Terminated |
| D-0511-2016 | 11-11-2015 | Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis, IN 46285, Repackaged by: Remedy Repack, Inc, 625 Kolter Dr, Indiana, PA 15701, NDC 52125-0415-08 | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. | RemedyRepack Inc. / 65 Vials | Class II | Terminated |
| D-0656-2016 | 11-11-2015 | SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-9. | Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast. | Fagron, Inc / 88 Bottles | Class II | Terminated |
| D-0513-2016 | 11-11-2015 | Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0873-02 | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. | RemedyRepack Inc. / 1 Vial | Class II | Terminated |
| D-0515-2016 | 11-11-2015 | Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0316-01 | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. | RemedyRepack Inc. / 1625 Vials | Class II | Terminated |
| D-0512-2016 | 11-11-2015 | Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma Inc., Bristol, TN 37620, Repackaged by: RemedyRepack, Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0253-03 | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. | RemedyRepack Inc. / 60 Vials | Class II | Terminated |
| D-0514-2016 | 11-11-2015 | Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0431-16 | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. | RemedyRepack Inc. / 1 Vial | Class II | Terminated |
| D-0654-2016 | 11-11-2015 | SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5. | Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast. | Fagron, Inc / 44 Bottles | Class II | Terminated |
| D-0516-2016 | 11-11-2015 | Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0414-01 | Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. | RemedyRepack Inc. / 106 Vials | Class II | Terminated |
| D-0655-2016 | 11-11-2015 | SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1167-9. | Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast. | Fagron, Inc / 148 Bottles | Class II | Terminated |
| D-0540-2016 | 11-10-2015 | IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 1 bag | Class II | Terminated |
| D-0546-2016 | 11-10-2015 | Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 21 syringes | Class II | Terminated |
| D-0551-2016 | 11-10-2015 | Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 7 bags | Class II | Terminated |
| D-0549-2016 | 11-10-2015 | Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 27 syringes | Class II | Terminated |
| D-0545-2016 | 11-10-2015 | Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe, c) 50 unit/0.5 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 23 syringes | Class II | Terminated |
| D-0558-2016 | 11-10-2015 | 3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 87 bags | Class II | Terminated |
| D-0527-2016 | 11-10-2015 | Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5 mL syringe, e) Heparin 800 units/0.8 f) Heparin 2300 units/2.3 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 49 syringes | Class II | Terminated |
| D-0555-2016 | 11-10-2015 | Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 9 bags | Class II | Terminated |
| D-0532-2016 | 11-10-2015 | Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 40 Minibags | Class II | Terminated |
| D-0547-2016 | 11-10-2015 | IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 5 bags | Class II | Terminated |
| D-0537-2016 | 11-10-2015 | Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 14 Accuflo bags | Class II | Terminated |
| D-0557-2016 | 11-10-2015 | 0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 7 bags | Class II | Terminated |
| D-0543-2016 | 11-10-2015 | Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 23 syringes | Class II | Terminated |
| D-0528-2016 | 11-10-2015 | Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL, c) Vancomycin 1G/NS 250 mL, d) 1.5G/NS 250 mL e) 750 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 95 Accuflo bags | Class II | Terminated |
| D-0550-2016 | 11-10-2015 | Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 30 Accuflo bags | Class II | Terminated |
| D-0548-2016 | 11-10-2015 | Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 63 Minibags | Class II | Terminated |
| D-0538-2016 | 11-10-2015 | Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 19 bags | Class II | Terminated |
| D-0529-2016 | 11-10-2015 | Piperacillin/Tazobactam (Zosyn) Accuflo bag, a) 18 g/NS 275 mL b) 4.5 g/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 26 Accuflo bags | Class II | Terminated |
| D-0552-2016 | 11-10-2015 | Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 1 bag | Class II | Terminated |
| D-0554-2016 | 11-10-2015 | Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 26 Minibags | Class II | Terminated |
| D-0536-2016 | 11-10-2015 | Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 35 Minibags | Class II | Terminated |
| D-0542-2016 | 11-10-2015 | Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 23 syringes | Class II | Terminated |
| D-0553-2016 | 11-10-2015 | Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 7 Accuflo bags | Class II | Terminated |
| D-0544-2016 | 11-10-2015 | Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 30 syringes | Class II | Terminated |
| D-0531-2016 | 11-10-2015 | L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 14 syringes | Class II | Terminated |
| D-0534-2016 | 11-10-2015 | Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 1 bag | Class II | Terminated |
| D-0485-2016 | 11-10-2015 | Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist By: West-Ward Pharmaceuticals Corp., Eatentown, NJ 07724 USA, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC 51655-320-53 | Labeling: Not elsewhere classified. NDC number is incorrect on the container. | Northwind Pharmaceuticals LLC / 40 Bottles | Class III | Terminated |
| D-0533-2016 | 11-10-2015 | Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Lack | Lack of Assurance of Sterility | Walgreens Infusion Services / 34 Accuflo bags | Class II | Terminated |
| D-0526-2016 | 11-10-2015 | Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 73 syringes | Class II | Terminated |
| D-0541-2016 | 11-10-2015 | Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 20 syringes | Class II | Terminated |
| D-0539-2016 | 11-10-2015 | Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 46 Minibags | Class II | Terminated |
| D-0556-2016 | 11-10-2015 | 0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Lack of Assurance of Sterility | Walgreens Infusion Services / 43 bags | Class II | Terminated |
