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-0361-2015 | 12-26-2014 | Acyclovir various strengths in normal saline | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0348-2015 | 12-26-2014 | Piperacillin/ tazobactam various strength in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0364-2015 | 12-26-2014 | Dobutamine various strengths in dextrose | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0360-2015 | 12-26-2014 | Tigecycline various strengths in normal saline | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0369-2015 | 12-26-2014 | Magnesium sulfate various strengths in sodium chloride | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0372-2015 | 12-26-2014 | Diphenhydramine 50 mg/ml vials | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0370-2015 | 12-26-2014 | Deferoxamine various strengths in normal saline | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class III | Terminated |
| D-0349-2015 | 12-26-2014 | Vancomycin various strengths in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0345-2015 | 12-26-2014 | Ceftazidime various strength in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0347-2015 | 12-26-2014 | Ertapenem various strength in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0351-2015 | 12-26-2014 | Meropenem various strengths in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0368-2015 | 12-26-2014 | Ranitidine various strengths in syringes | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0357-2015 | 12-26-2014 | Ceftriaxone various strengths in normal saline | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0373-2015 | 12-26-2014 | Immune globulin g human various strengths | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0374-2015 | 12-26-2014 | L-cysteine various strengths | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0340-2015 | 12-26-2014 | Liposomal Amphotericin B 130 mg in dextrose bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0356-2015 | 12-26-2014 | Daptomycin various strengths in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0346-2015 | 12-26-2014 | Imipenem/ cilastatin various strength in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0375-2015 | 12-26-2014 | Total parenteral nutrition various strengths | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0344-2015 | 12-26-2014 | Cefoxitin various strength in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0353-2015 | 12-26-2014 | Cefazolin various strengths in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0362-2015 | 12-26-2014 | Milrinone various strengths in dextrose | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0359-2015 | 12-26-2014 | Linezolid various strengths in dextrose | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0371-2015 | 12-26-2014 | Dehydrated alcohol vials | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0354-2015 | 12-26-2014 | Tobramycin various strengths in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0363-2015 | 12-26-2014 | Caspofungin various strengths in normal saline | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0341-2015 | 12-26-2014 | Amikacin various strength in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0352-2015 | 12-26-2014 | Nafcillin various strengths in sterile water for injection bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0350-2015 | 12-26-2014 | Cefuroxime various strengths in normal saline bags | Lack of sterility assurance. | Walgreens Infusion Services / N/A | Class II | Terminated |
| D-0325-2015 | 12-23-2014 | Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; 100-bottle capsules - NDC 68382-247-01 500-bottle capsules - NDC 68382-247-05 Package NDCs: 68382-247-01; 68382-247-05; 68382-091-01 | Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. | Zydus Pharmaceuticals USA Inc / 19,536 units | Class II | Terminated |
| D-0380-2015 | 12-23-2014 | Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446. Package NDCs: 0338-6046-48; 0338-6045-37 | Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam. | Baxter Healthcare Corp. / 31,130 bags | Class II | Terminated |
| D-0381-2015 | 12-23-2014 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, 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: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron. | Hospira Inc. / 126,075 vials | Class II | Terminated |
| D-0334-2015 | 12-22-2014 | 0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11 | Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port. | Hospira Inc. / 30840 bags | Class II | Terminated |
| D-0331-2015 | 12-22-2014 | ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 | Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol. | Qualitest Pharmaceuticals / a) 3936 bottles; b) 84420 bottles | Class III | Terminated |
| D-1207-2015 | 12-19-2014 | SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc. | Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis. | Bethel Nutritional Consulting, Inc / UNKNOWN | Class I | Terminated |
| D-0376-2015 | 12-19-2014 | 3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878-3130-04), Rx Only, Manufactured for 3M ESPE Dental Products, St. Paul, MN 55144 | Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box.. | 3M Company/3m Espe Dental Products / 19,728 tubes | Class III | Terminated |
| D-0424-2015 | 12-19-2014 | B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040. | Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss | Bethel Nutritional Consulting, Inc / UNKNOWN | Class II | Terminated |
| D-469-2015 | 12-17-2014 | Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm , Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 2 bags | Class I | Terminated |
| D-446-2015 | 12-17-2014 | Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 4 bags | Class I | Terminated |
| D-453-2015 | 12-17-2014 | Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, Dextrose 10%, Additives: heparin PF 0.5 unit(s)/mL, Calcium Gluconate 600mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 6 bags | Class I | Terminated |
| D-444-2015 | 12-17-2014 | Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamine 2% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 1 bag | Class I | Terminated |
| D-467-2015 | 12-17-2014 | Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM, Trophamine 4g/dL, Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 5 bags | Class I | Terminated |
| D-466-2015 | 12-17-2014 | Bayshore Medical Center (TX) 5% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 5%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 3 bags | Class I | Terminated |
| D-442-2015 | 12-17-2014 | Bridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 4 bags | Class I | Terminated |
| D-451-2015 | 12-17-2014 | Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% without Ca, Trophamine 12g, Dextrose 20g, compound vol: 200 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 5 bags | Class I | Terminated |
| D-0328-2015 | 12-17-2014 | Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN | Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli | Tropichem Research Labs, Inc. / 24,348 / 2 oz. bottles | Class II | Terminated |
| D-456-2015 | 12-17-2014 | Truman Medical Center Lakewood (MO) Trophamine UAC Solution, Trophamine 3.2g, compound vol: 100 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 5 bags | Class I | Terminated |
| D-440-2015 | 12-17-2014 | Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 2 bags | Class I | Terminated |
| D-450-2015 | 12-17-2014 | Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, Additives: Calcium Gluconate 1500 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 4 bags | Class I | Terminated |
| D-447-2015 | 12-17-2014 | Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dextrose 5%, Additives: heparin PF 100 units/mL, 50 units/dL, Calcium Gluconate 0.46 mEq/mL, 200 mg/dL, compound vol: 300 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 3 bags | Class I | Terminated |
| D-460-2015 | 12-17-2014 | Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 200mg/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 20 bags | Class I | Terminated |
| D-439-2015 | 12-17-2014 | Rose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 8 bags | Class I | Terminated |
| D-452-2015 | 12-17-2014 | Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dextrose 20g, Additives: Calcium Gluconate 8mEq, compound vol: 200 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 5 bags | Class I | Terminated |
| D-457-2015 | 12-17-2014 | Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, Additives: Calcium Gluconate 0.46mEq/mL, 7mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 10 bags | Class I | Terminated |
| D-437-2015 | 12-17-2014 | University of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box. each container is lined with a polystyrene insert; CAPS, Allentown, PA | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 20 bags | Class I | Terminated |
| D-464-2015 | 12-17-2014 | Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10%, Additives: heparin PF 62.5 units, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 6 bags | Class I | Terminated |
| D-470-2015 | 12-17-2014 | Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 12 bags | Class I | Terminated |
| D-445-2015 | 12-17-2014 | Advocate Good Samaritan Hospital (IL) TPN Dextrose 5% Trophamine 2%, Trophamine 5% Dextrose 2%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 4 bags | Class I | Terminated |
| D-455-2015 | 12-17-2014 | Truman Medical Center Lakewood (MO) Starter TPN, Trophamine 5.25g, Dextrose 10%, Additives: Calcium Gluconate 4.8mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 5 bags | Class I | Terminated |
| D-441-2015 | 12-17-2014 | The Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 2 bags | Class I | Terminated |
| D-449-2015 | 12-17-2014 | Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 10 bags | Class I | Terminated |
| D-463-2015 | 12-17-2014 | Abington Memorial Hospital (PA) TPN Neonatal Starter> 1Kg, Amino Acids, Neonate 12.5g, Dextrose 10%, 500 ml, Additives: heparin PF 250 units, Calcium Gluconate 1250mg, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 6 bags | Class I | Terminated |
| D-454-2015 | 12-17-2014 | St Lukes East Lees Summit (MO) Protein Bag,Trophamine 5g, Dextrose 10%, Additives: Calcium Gluconate 4.65mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 6 bags | Class I | Terminated |
| D-462-2015 | 12-17-2014 | Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 1 bag | Class I | Terminated |
| D-0326-2015 | 12-17-2014 | Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLC, Peapack, NJ, 07977, a) NDC 59762-3719-3, b) NDC 59762-3719-4. Package NDCs: 59762-3719-1; 59762-3719-3; 59762-3719-4; 59762-3720-1; 59762-3720-3; 59762-3720-4; 59762-3721-1; 59762-3721-3; 59762-3721-4; 59762-3722-1; 59762-3722-3 | Subpotent Drug | Neolpharma, Inc. / 12,310 bottles | Class II | Terminated |
| D-468-2015 | 12-17-2014 | Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Trophamine 5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46 mEq/mL, 750mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 2 bags | Class I | Terminated |
| D-465-2015 | 12-17-2014 | Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 3 bags | Class I | Terminated |
| D-458-2015 | 12-17-2014 | Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 4 bags | Class I | Terminated |
| D-443-2015 | 12-17-2014 | Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine 4% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 2 bags | Class I | Terminated |
| D-461-2015 | 12-17-2014 | Abington Memorial Hospital (PA) TPN Neonatal Starter 0.6-0.99 Kg, Amino Acids, Neonate 5g, Dextrose 7.5%, 250 ml, Additives: heparin PF 125 unit(s)/ml, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 4 bags | Class I | Terminated |
| D-438-2015 | 12-17-2014 | Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, Trophamine 4% Dextrose 10%, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 10 bags | Class I | Terminated |
| D-448-2015 | 12-17-2014 | Olathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamine 3g Dextrose 10%, Additives: Calcium Gluconate 250mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 1 bag | Class I | Terminated |
| D-459-2015 | 12-17-2014 | Robert Wood Johnson University (NJ) Neonatal Starter 5% Dextrose, Trophamine 5%, Dextrose 5%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA. | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. / 2 bags | Class I | Terminated |
| D-0327-2015 | 12-16-2014 | J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 mL) Bottle, Over the Counter. Manufactured for JayMac Pharmaceuticals, LLC, Sunset, LA; Manufactured by Sonar Products Inc., Carlstadt, NJ, NDC: 64661-032-30. | Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40. | Jaymac Pharmaceuticals L.L.C. / 5572 Bottles | Class II | Terminated |
| D-0337-2015 | 12-15-2014 | Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11 Package NDCs: 59088-725-00; 45963-556-11 | Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center. | Actavis Elizabeth LLC / 24,240 Bottles | Class II | Terminated |
| D-0338-2015 | 12-15-2014 | Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA. Package NDCs: 45963-555-11; 45963-555-50; 45963-556-11; 45963-556-50; 45963-557-11; 45963-557-50 | Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center. | Actavis Elizabeth LLC / 29,622 Bottles | Class II | Terminated |
| D-0336-2015 | 12-15-2014 | Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA. Package NDCs: 45963-555-11; 45963-555-50; 45963-556-11; 45963-556-50; 45963-557-11; 45963-557-50; 14550-513-02 | Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center. | Actavis Elizabeth LLC / 10,857 Bottles | Class II | Terminated |
| D-0988-2015 | 12-12-2014 | ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-dione 15mg, 2a-3a-epithio-17a-methyl-5a-androstan-17b-ol 10 mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789 | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. | Anabolic Science Labs, LLC / 12,166 bottles | Class I | Terminated |
| D-0989-2015 | 12-12-2014 | SWOLL-250 SUPER MASS BUILDER QUAD STACK (18-Methylestr-4-en-3-one-17b-ol 15mg, 6-a-Chloro-androst-4-en-17b-ol-3-one 15mg, 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one 15mg, 2,17a-dimethyl-5a-androsta-1-en-17b-ol-3-one 3 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789 | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. | Anabolic Science Labs, LLC / 10,829 bottles | Class I | Terminated |
| D-0987-2015 | 12-12-2014 | 7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789 | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. | Anabolic Science Labs, LLC / 3,808 bottles | Class I | Terminated |
| D-0984-2015 | 12-12-2014 | M1-ALPHA LABS MEGA MASS BUILDER (M1A, Methyl-1-Etiocholenolol- 20mg, Epietiocholanolone) Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789 | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. | Anabolic Science Labs, LLC / 3,638 bottles | Class I | Terminated |
| D-0335-2015 | 12-12-2014 | Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376. | Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial. | Right Value Drug Stores, Inc. / a) 26 vials, b) 15 vials, c) 16 vials | Class II | Terminated |
| D-0986-2015 | 12-12-2014 | HALO-70 MEGA MASS BUILDER (4-chloro-17a-methyl-androst-1,4-diene-3b,17b-diol 35mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789 | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. | Anabolic Science Labs, LLC / 515 bottles | Class I | Terminated |
| D-0985-2015 | 12-12-2014 | M14-MENT ADVANCED MASS BUILDER (7a-Methyl-estra-4-en-3,17-dione MENT 5mg, M14D 20 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789 | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. | Anabolic Science Labs, LLC / 1,479 bottles | Class I | Terminated |
| D-0990-2015 | 12-12-2014 | PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg: 13-dimethyl-1,2,7,8,9,11,12,14,15,16-decahydro-cyclopenta[a]phenanthrene-3,6,17-trione,4-Androsten 4,17-beta-diol-3one), Capsules, 60 count bottle, Manufactured for: ANABOLIC SCIENCE LABS WINTER PARK, FL 32789 | Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. | Anabolic Science Labs, LLC / 22,353 bottles | Class I | Terminated |
| D-0427-2015 | 12-12-2014 | Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27 | Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product | American Specialty Pharmacy / 15 vials | Class II | Terminated |
| D-0318-2015 | 12-09-2014 | sulfur8(R) medicated anti-dandruff conditioner, dandruff treatment for Braids, spray, Active Ingredient: Salicylic Acid, 2%, 12 FL OZ (356ml) spray bottle, OTC, Made in the U.S.A. J. Strickland & Co., OLIVE BRANCH, MS 38654 UPC: 0 7561044510 7 | Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5. | J. Strickland and Co / 1506 (case of 12) | Class III | Terminated |
| D-0333-2015 | 12-09-2014 | Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60). | Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point. | Akorn, Inc. / 3,937 bottles | Class III | Terminated |
| D-0291-2015 | 12-05-2014 | Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01 | Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule. | Sandoz Incorporated / 1,008 bottles | Class III | Terminated |
| D-0302-2015 | 12-05-2014 | BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmaceuticals, GmbH, Zofingen, Switzerland, Distributed by: Elsai Inc., Woodcliff, NJ 07677 NDC 62856-52960. | Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date. | Eisai Inc / 121,680 bottles | Class III | Terminated |
| D-0407-2015 | 12-04-2014 | Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540 | Failed Impurities/Degradation Specifications: Product failed a known impurity specification. | Micro Labs Usa, Inc S / 240 (1000-count bottle), 26,904 (90-count bottle) | Class III | Terminated |
| D-0322-2015 | 12-04-2014 | Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Manufactured for: Petragon, Inc., Edwardsville, KS 66111; b) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355, UPC: 6 69635 24082 5; c) Xpect First aid, Manufactured for Cintas First Aid & Safety, Mason, OH 45040; d) ZEE, Distributed by ZEE MEDICAL, INC., Irvine, CA 92606, UPC: 6 90689 00609 9. | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy. | K C Pharmaceuticals Inc / 71904 Bottles | Class III | Terminated |
| D-0408-2015 | 12-04-2014 | Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90. | Failed Impurities/Degradation Specifications: Product failed a known impurity specification. | Micro Labs Usa, Inc S / 13488 bottles | Class III | Terminated |
| D-0321-2015 | 12-04-2014 | Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Astringent Redness Reliever, Distributed by Safeway Inc., P.O. Box 99, Pleasanton, CA 94566-0009, UPC: 3 21130 70067 8; b) Best Choice, Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 47010 6; c) EQUALINE, Distributed by Supervalu Inc., Eden Prairie, MN, UPC: 0 41163 25114 4; d) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pomona, CA 91768, UPC: 1 80410 00018 7, NDC: 48879-010-07; e) H-E-B, Made for: H-E-B, San Antonio, TX 78204, UPC: 0 41220 86936 7; f) healthy accents, Distributed by: DZA Brands, LLC 2110 Executive Drive, Salisbury, NC 28147, UPC: 7 25439 93382 7; g) HyVee, Distributed By Hy-Vee, Inc., 5820 Westown Parkway, West Des Moines, IA 50266, UPC: 0 75450 29777 5; h) Kroger, Distributed by The Kroger Co., Cincinnati, Ohio 45202, UPC: 0 11110 38599 4; i) life, Imported for/Importe pour: SHOPPERS DRUG MART PHARMAPRIX., Toronto, M2J 4W8, by/par: Arrow OTC Inc., Mississauga, Ontario L5N 2B8, UPC: 0 57800 19617 4; j) LiveBetter, Distributed By Onpoint. Inc., 2 Paragon Drive, Montvale, NJ 07645, UPC: 0 41310 62041 0; k) meijer, Dist. by Meijer Distribution, Inc., 2929 Walker Ave NW, Grand Rapids, MI 49544, UPC: 0 41250 82918 8; l) Publix, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, UPC: 0 41415 01176 2; m) QUALITY CHOICE, Distributed by Quality Choice, Novi, MI 48376, UPC: 6 35515 99505 5; n) REDNESS RELIEF ASTRINGENT, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC: 0 50428 79686 3; o)Rexall, Manufactured for: Rexall Brands Corp., Mississauga, Ontario L4Z 1R9, Imported by: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10159 8; p) Rexall, Fabrique pour: Rexall Brands Corp., Mississauga, Ontario L4Z 1R9, Importe par: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10159 8; q) select brand, Distributed by: SELECT BRAND DISTRIBUTORS, Pine Bluff, AR 71603, UPC: 0 15127 00363 6; r) Smart sense, Distributed by: Kmart Corporation, Hoffman Estates, IL 60179, UPC: 7 20007 96092 2; s) TopCare, Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, IL 60077, UPC: 0 36800 03640 6; t)WESTERN FAMILY, Distributed by Western Family Foods, Inc., P.O. Box 4057 Portland, OR 97208, UPC: 0 15400 04552 0. | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy. | K C Pharmaceuticals Inc / 302,976 Bottles | Class III | Terminated |
| D-0320-2015 | 12-04-2014 | Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Best Choice, DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, 0 70038 47011 3; b) CVP, Distributed by Salado Sales, Inc., Temple, Texas 76503, UPC: 7 61706 16500 3; c) Equaline, DISTRIBUTED BY SUPERVALU INC. EDEN PRAIRIE, MN 55344, UPC: 0 41163 25110 6; d) exact, Prepared For/Prepare Pour: Loblaws Inc., Montreal H4N 3L4, Tonronto M4T 2S8, Calgary T2E 7S9, CANADA, Imported by/Importe par: Arrow OTC, Mississauga, ON L5N 2B8, UPC: 0 60383 73613 2; e) FAMILY wellness, Distributed by: Family Dollar Services, Inc., 10401 Monroe Rd., Matthews, NC 28105, UPC: 0 32251 00459 9; f) Good Neighbor Pharmacy, Distributed By: AmerisourceBergen 1300 Moris Drive, Chesterbrook, PA 19087, UPC: 0 87701 14975 7, NDC: 24385-075-05; g) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pomona, CA 91768, UPC: 1 80410 00015 6, NDC: 48879-009-07; h) H-E-B, Made with Pride and Care for H-E-B, San Antonio, TX 78204, UPC: 0 41220 94731 7; i) Health Mart PHARMACY, Distributed by McKesson One Post STreet, San Francisco, CA 94104, UPC: 0 52569 13472 6, NDC: 62011-0102-1; j) healthy accents, Distributed by: DZA Brands, LLC, 2110 Executive Drive, Salisbury, NC 28147, UPC: 7 25439 93380 3; k) HyVee, Distributed by HY-VEE, Inc., 5820 Westown Parkway, West Des Moines, IA 50266, UPC: 0 75450 29604 4; l) Kroger, Distributed by The Kroger Co., Cincinnati, Ohio 45202, UPC: 0 11110 38597 0; m) life BRAND, Imported for SHOPPERS DRUG MART PHARMAPRIX, Toronto, M2J 4W8, UPC: 057800-19616-7; n) life BRAND, Importe pour: SHOPPERS DRUG MART PHARMAPRIX, Toronto, M2J 4W8, UPC: 0 57800 19616 7; o) LiveBetter, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, UPC: 0 41310 62042 7; p) meijer, Dist. By Meijer Distribution, Inc., 2929 Walker Ave NW, Grand Rapids, MI 49544, UPC: 0 41250 82916 4; q) Our Family, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN, 55435, UPC: 0 70253 96684 2; r) Publix, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, UPC: 0 41415 01076 5; s) Redness Relief, Distributed by: Safeway Inc., P.O. BOX 99, PLEASANTON, CA 94566-0009, UPC: 3 21130 70060 9; t) Rexall, Manufactured For: Rexall Brads Corp., Mississauga, Ontario, L4Z 1R9., Imported by: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10160 4; u) Rexall, Fabrique pour: Rexall Brands Corp., Mississauga, Ontario L4Z 1%9, Importe par: Arrow OTC Company, Mississauga, Ontario l5N 2B8, UPC: 7 71058 10160 4; v) select brand, Distributed by: SELECT BRAND DISTRIBUTORS, Pine Bluff, AR 71603, UPC: 0 15127 00066 6; w) Smart sense, Distributed by: Kmart Corgoration, Hoffman Estates, IL 60179, UPC: 7 20007 78036 0; x) sunmark, Cistributed By McKesson, One Post Street, San Francisco, CA 94104, UPC: 0 10939 16733 0, NDC: 49348-037-29; y) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355; UPC: 6 69635 24061 0; z) TopCare, Distributed By Topco Associates LLC, 7711 Gross Point Road, Skokie, IL 60077, UPC: 0 36800 03639 0; aa) Western Family Foods, Distributed by: Western Family Foods, Inc., P.O. Box 4059, Portland, OR 97208, UPC:0 15400 03420 3;bb) ZEE, Distributed by ZEE MEDICAL, INC., Irvine, CA 92606, UPC: 6 90689 00614 3. Package NDCs: 49348-037-29; 24385-075-05; 48879-009-07; 62011-0102-1 | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy. | K C Pharmaceuticals Inc / 751,440 Bottles | Class III | Terminated |
| D-481-2015 | 12-04-2014 | 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18. Package NDCs: 0338-0553-11; 0338-0553-18 | Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter. | Baxter Healthcare Corp / 542,080 container bags | Class I | Terminated |
| D-0323-2015 | 12-04-2014 | Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Advanced Relief, Distributed by Safeway Inc., P.O.Box 99, Pleasanton, CA 94566-0009, UPC: 3 21130 70064 7; b) Best Choice, Distributed By: Valu Mercahndisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 47009 0; c) EQUALINE, Distributed By Supervalu Inc., Eden Prairie, MN 55344, UPC: 0 41163 25392 6; d) equate, Manufactured for/Fabrique pour: Wal-Mart Canada Corp, 1940 Argentia Rd, Mississauga Ontario L5N 1P9, Imported by/ Importe par: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 1 83164 00022 9; e) exchange select, Manufactured For: Your Military Exchanges By: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC: 6 14299 39625 8; f) GOOD NEIGHBOR PHARMACY, Distributed By AmerisourceBergen 1300 Morris Drive, Chesterbrook, PA 19087, UPC: 0 87701 10663 7, NDC: 24385-077-05; g) GOODSENSE, Manufactured By: KC Pharmaceuticals, Pomona, CA 91768, UPC: 1 80410 00019 4, NDC: 48879-007-07; h) H-E-B, Made for H-E-B, San Antonio, TX 78204, UPC: 0 41220 89137 5; i) Health Mart, Distributed by McKesson, One Post Street, San Francisco, CA 94104, UPC: 0 52569 13474 0, NDC: 62011-0104-1; j) healthy accents, Distributed by: DZA Brands, LLC, 2110 Executive Drive, Salisbury, NC 28147, NDC: 7 25439 93383 4; k) HyVee, Distributed By Hy-Vee, Inc., 5820 Westown Parkway, West Des Moines, IA 50266, UPC: 0 75450 29778 2; l) Kroger, Distributed by The Kroger Co., Ohio 45202, UPC: 0 11110 38598 7; m) life, Imported for/ Importe pour: SHOPPERS DRUG MART PHARMAPRIX, Toronto, M2J 4W8, by/par: Arrow OTC Inc., Mississauga, Ontario L5N 2B8, UPC: 0 57800 15640 6; n) LiveBetter, Distributed by Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, UPC: 0 41310 62043 4; o) Medic's Choice, KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC: 0 95072 01251 8, NDC: 055654-025; p) meijer, Dist. By Meijer Distribution, Inc., 2929 Walker Ave NW, Grand Rapids, MI 49544, UPC: 0 41250 82917 1; q) Our Family, Distributed by NASH FINCH COMPANY, NFC Brands, 7600 France Ave S, MPLS 55435, UPC: 0 70253 96683 5; r) Publix, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, UPC: 0 41415 06776 9; s) Rexall, Manufactured for: Rexall Brands Corp., Mississauga, Ontario L5N 2B8, Imported by: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10462 8; t) Rexall, Fabrique pour: Rexall Brands Corp., Mississauga, Ontario L5N 2B8, Importe par: Arrow OTC Company, Mississauga, Ontario L5N 2B8, UPC: 7 71058 10462 8; u) select brand, Distributed by: SELECT BRAND DISTRIBUTORS, Pine Bluff, AR 71603, UPC: 0 15127 00364 3; v) sunmark, Distributed By McKesson, One Post Street, San Francisco, CA 94104, UPC: 0 10939 16833 7, NDC: 49348-697-29; w) TopCare, Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, IL 60077, UPC: 0 36800 03641 3; x) WESTERN FAMILY, Distributed by Western Family Foods, Imc., P.O.Box 4057, Portland OR 97208, UPC: 0 15400 03281 0. Package NDCs: 49348-697-29; 24385-077-05; 48879-007-07; 62011-0104-1 | CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy. | K C Pharmaceuticals Inc / 427,512 Bottles | Class III | Terminated |
| D-0409-2015 | 12-04-2014 | Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90. Package NDCs: 42571-010-30; 42571-010-60; 42571-010-90; 42571-010-05; 42571-010-10; 42571-005-30; 42571-005-60; 42571-005-90; 42571-005-05; 42571-005-10; 42571-020-30; 42571-020-60; 42571-020-90; 42571-020-05; 42571-020-10; 42571-040-30; 42571-040-60; 42571-040-90; 42571-040-05; 42571-040-10; 42571-080-30; 42571-080-60; 42571-080-90; 42571-080-05; 42571-080-10 | Failed Impurities/Degradation Specifications: Product failed a known impurity specification. | Micro Labs Usa, Inc S / 13464 bottles | Class III | Terminated |
| D-0292-2015 | 12-03-2014 | Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017. Package NDCs: 0069-5800-61; 0069-5800-60; 0069-5800-43; 0069-5810-61; 0069-5810-60; 0069-5810-43; 0069-5820-61; 0069-5820-60; 0069-5820-43 | Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules. | Pfizer Inc. / 31,569 HDPE Bottles | Class II | Terminated |
| D-0433-2015 | 12-03-2014 | MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66). Package NDCs: 61703-343-18; 61703-343-65; 61703-343-66 | Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities. | Hospira Inc. / 13,792 Vials (U.S.) | Class I | Terminated |
