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-0317-2017 | 11-17-2016 | TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/10mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 5 vials | Class II | Ongoing |
| D-0246-2017 | 11-17-2016 | Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 mg/Thiamine HCL 50 mg/Riboflavin-5-Phosphate Sod 5 mg/Niacinamide 20 mg/Pyridoxine HCL 2 mg/Folic Acid 2 mg/Ascorbic Acid 50 mg/Chromium Picolinate 200 mcg/Glutamine (L) 30 mg/Lidocaine HCL 10 mg/mL). Compounded by Tri-Coast Pharmacy. | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 59 vials | Class II | Ongoing |
| D-0264-2017 | 11-17-2016 | Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL). 30 ML. Compounded by Tri-Coast Pharmacy. | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 161 vials | Class II | Ongoing |
| D-0273-2017 | 11-17-2016 | Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL, 1 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 99 vials | Class II | Ongoing |
| D-0277-2017 | 11-17-2016 | Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + Sodium Molybdate 250 mcg/ml + Strontium Chloride 3 mg/ml + Lithium Citrate 5 mg/ml + Chromium Picolinate 100 mcg/ml + Boron Citrate 1798 mg/ml + Sodium Selenite 200 mcg.ml + Cupric Sulfate 1 mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 36 vials | Class II | Ongoing |
| D-0288-2017 | 11-17-2016 | Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 54 vials | Class II | Ongoing |
| D-0299-2017 | 11-17-2016 | Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 2,818 vials | Class II | Ongoing |
| D-0259-2017 | 11-17-2016 | Glutamine 25 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 12 vials | Class II | Ongoing |
| D-0308-2017 | 11-17-2016 | Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 78 vials | Class II | Ongoing |
| D-0267-2017 | 11-17-2016 | L-Carnitine 250 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 14 vials | Class II | Ongoing |
| D-0292-2017 | 11-17-2016 | Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Tri-Coast Pharmacy / 441 vials | Class II | Ongoing |
| D-0172-2017 | 11-17-2016 | SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmaceutica (Portugal,) SA Distributed by: Westward Eatowntown NJ 07724 USA, Shelf pack NDC 0143-9570-10, Unit dose NDC 0143-9570-01 Package NDCs: 0143-9570-01; 0143-9570-10 | Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing. | West-Ward Pharmaceuticals Corp. / 5,142 Shelf-packs | Class III | Terminated |
| D-0152-2017 | 11-14-2016 | Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY | Failed Stability Specifications; out-of specification value for homogeneity / phase separation. | Akorn Inc / a) 62 tubes and b) 91 tubes | Class II | Terminated |
| D-0210-2017 | 11-13-2016 | Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007. | Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall. | Ultimate Body Tox / 25 bottles | Class I | Terminated |
| D-0140-2017 | 11-09-2016 | L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540. | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised. | Sandoz Inc / 18,751 vials | Class II | Terminated |
| D-0146-2017 | 11-09-2016 | Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771. | Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia. | VistaPharm, Inc. / 1497 cases | Class II | Terminated |
| D-0141-2017 | 11-09-2016 | L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ. | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised. | Sandoz Inc / 33,624 vials | Class II | Terminated |
| D-0235-2017 | 11-08-2016 | Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v Chloroxylenol), packaged in a) 4 oz. bottles (NDC 46706-201-01), b) 8 oz bottles (NDC 46706-201-02), c) 16 oz. bottles (NDC 46706-201-03), d) 12 oz. pumpette (NDC 46706-201-05), e) 32 oz. bottles (NDC 46706-201-06), OTC, Care-Tech Laboratories, Inc., St. Louis, MO 63139 | Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps. | Care-Tech Laboratories, Inc. / 106,506 bottles: 1761/4oz.; 241/ 8oz.; 107/12oz.; 439/ 16oz; 241/32 oz. | Class III | Terminated |
| D-0150-2017 | 11-07-2016 | LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Superpotent | Pfizer Inc. / 2,666 bottles | Class II | Terminated |
| D-0147-2017 | 11-04-2016 | Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01 Package NDCs: 0143-9886-01; 0143-9886-50; 0143-9886-75; 0143-9887-01; 0143-9887-50; 0143-9887-75 | Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed. | West-Ward Pharmaceuticals Corp. / 32,102 bottles | Class III | Terminated |
| D-0151-2017 | 11-03-2016 | Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA | Failed Impurities/Degradation Specifications: OOS results for known compound. | Mylan Pharmaceuticals Inc. / 51,983 extended release capsules | Class III | Terminated |
| D-0173-2017 | 11-02-2016 | PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110. | Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data. | Fallon Wellness Pharmacy, L.L.C. / 10 vials | Class II | Terminated |
| D-0174-2017 | 11-02-2016 | PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110. | Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data. | Fallon Wellness Pharmacy, L.L.C. / 5 vials | Class II | Terminated |
| D-0163-2017 | 11-02-2016 | Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10 Package NDCs: 67877-217-01; 67877-217-05; 67877-217-10; 67877-217-33; 67877-217-38; 67877-218-01; 67877-218-05; 67877-218-10; 67877-218-33; 67877-218-38; 67877-221-01; 67877-221-05; 67877-221-10; 67877-221-33; 67877-221-38; 67877-413-01; 67877-413-05; 67877-413-10; 67877-413-33; 67877-413-90; 67877-414-01; 67877-414-05; 67877-414-10; 67877-414-33; 67877-414-90 | Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP | Ascend Laboratories LLC / 1739 bottles | Class II | Terminated |
| D-0207-2017 | 11-02-2016 | BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Package NDCs: 68382-354-06; 68382-354-16; 68382-354-05; 68382-354-10; 68382-353-06; 68382-353-16; 68382-353-05; 68382-353-10 | Failed Dissolution Specifications; 6 month time point | Zydus Pharmaceuticals USA Inc / 16,356 bottles | Class III | Terminated |
| D-0153-2017 | 11-01-2016 | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32 | Lack of Assurance of Sterility: Complaints of broken tips on the ampules. | Hospira Inc. / 797,800 ampules | Class II | Terminated |
| D-0171-2017 | 11-01-2016 | Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13. | Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing. | Teva Pharmaceuticals USA / N/A | Class III | Terminated |
| D-0170-2017 | 11-01-2016 | Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples). | Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing. | Teva Pharmaceuticals USA / 201, 234 Canisters | Class III | Terminated |
| D-0223-2017 | 10-28-2016 | Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle | Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein. | Love My Tru Body / 74 bottles | Class I | Terminated |
| D-0168-2017 | 10-28-2016 | Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10. | CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. | Nationwide Laboratories, LLC / 5,786,653 tablets | Class II | Terminated |
| D-0165-2017 | 10-28-2016 | Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830. | CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. | Nationwide Laboratories, LLC / 2,882,661 tablets | Class II | Terminated |
| D-0167-2017 | 10-28-2016 | Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10. | CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. | Nationwide Laboratories, LLC / 6,333,669 tablets | Class II | Terminated |
| D-0166-2017 | 10-28-2016 | Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830. | CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. | Nationwide Laboratories, LLC / 2,514,500 tablets | Class II | Terminated |
| D-0148-2017 | 10-28-2016 | KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8. | Failed Stability Specifications: Low Out of Specification results for alcohol content. | Sun Pharmaceutical Industries, Inc. / 326,103 bottles | Class III | Terminated |
| D-0137-2017 | 10-27-2016 | Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories | Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples. | Amerisource Health Services / a) 15,409 bottles b) 5,128 bottles | Class III | Terminated |
| D-0159-2017 | 10-24-2016 | AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10 | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures | Burel Pharmaceuticals Inc / 604 bottles | Class II | Terminated |
| D-0161-2017 | 10-24-2016 | Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10 | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures | Burel Pharmaceuticals Inc / 17,788 bottles | Class II | Terminated |
| D-0162-2017 | 10-24-2016 | Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10 | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures | Burel Pharmaceuticals Inc / 35,149 bottles | Class II | Terminated |
| D-0156-2017 | 10-24-2016 | UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures | Burel Pharmaceuticals Inc / 11,539 bottles | Class II | Terminated |
| D-0160-2017 | 10-24-2016 | Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10 | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures | Burel Pharmaceuticals Inc / 795 bottles | Class II | Terminated |
| D-0155-2017 | 10-24-2016 | Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90 | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures | Burel Pharmaceuticals Inc / 2861 bottles | Class II | Terminated |
| D-0158-2017 | 10-24-2016 | UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10 | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures | Burel Pharmaceuticals Inc / 823 bottles | Class II | Terminated |
| D-0157-2017 | 10-24-2016 | URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-300-10 | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures | Burel Pharmaceuticals Inc / 2,771 bottles | Class II | Terminated |
| D-0124-2017 | 10-21-2016 | Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12. | Subpotent Drug: concentration of product is less than labeled amount. | Akorn Inc / 29,972 bottles | Class II | Terminated |
| D-0138-2017 | 10-20-2016 | FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05 | Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL | CutisPharma, Inc. / 8,748 kits | Class III | Terminated |
| D-0139-2017 | 10-20-2016 | FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03 | Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL | CutisPharma, Inc. / 5904 kits | Class III | Terminated |
| D-0145-2017 | 10-19-2016 | Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01 Package NDCs: 0409-7337-11; 0409-7337-01; 0409-7338-11; 0409-7338-01; 0409-7332-11; 0409-7332-01; 0409-7335-13; 0409-7335-03 | Labeling: Missing Label | Sandoz Inc / 139,430 vials | Class III | Terminated |
| D-0224-2017 | 10-19-2016 | Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02 | Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse. | Inventia Healthcare Private Limited / 46,848 delayed-release capsules | Class II | Terminated |
| D-0115-2017 | 10-19-2016 | Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60 Package NDCs: 50458-540-60; 50458-540-91; 50458-541-60; 50458-541-91; 50458-542-60; 50458-542-91; 50458-543-60; 50458-543-91; 50458-940-01; 50458-940-02; 50458-941-01; 50458-941-02; 50458-942-01; 50458-942-02; 50458-943-01; 50458-943-02 | Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert. | Janssen Ortho L.L.C. / 5346 bottles | Class III | Terminated |
| D-0436-2017 | 10-18-2016 | HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459 | Subpotent Drug: due to failed potency results of 74% (spec. 80-125%). | Town and Country Compounding and Consultation Services, LLC / 101 vials | Class III | Terminated |
| D-0142-2017 | 10-18-2016 | Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01 | Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot". | GSK Consumer Healthcare / 462,732 bottles | Class III | Terminated |
| D-0144-2017 | 10-13-2016 | AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 | Presence of Foreign Tablets/Capsules | Amerisource Health Services / 5283 cartons (100 capsules per carton = 528,300 capsules) | Class III | Terminated |
| D-0468-2017 | 10-13-2016 | Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30 Package NDCs: 55111-163-30; 55111-163-01; 55111-163-05; 55111-163-79; 55111-163-78 | Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station. | Dr. Reddy's Laboratories, Inc. / 5,904 bottles | Class III | Terminated |
| D-0426-2017 | 10-12-2016 | Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04 | Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct | Pharm D Solutions, LLC / 4 mL: 510 vials, 5 mL: 486 vials | Class III | Terminated |
| D-0125-2017 | 10-12-2016 | Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65. | Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation. | Pharmedium Services, LLC / 1550 units | Class II | Terminated |
| D-0427-2017 | 10-12-2016 | HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20 | Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct | Pharm D Solutions, LLC / 112 bottles | Class III | Terminated |
| D-0113-2017 | 10-06-2016 | Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0019-01 | Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole. | Boehringer Ingelheim Pharmaceuticals, Inc. / 2562 bottles | Class II | Terminated |
| D-0114-2017 | 10-06-2016 | DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25 | Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole. | Boehringer Ingelheim Pharmaceuticals, Inc. / 6400 bottles | Class II | Terminated |
| D-0143-2017 | 10-06-2016 | NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10 | Presence of Foreign Tablets/Capsules | Actavis Elizabeth LLC / 27,517 bottles | Class III | Terminated |
| D-0154-2017 | 10-05-2016 | Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977 | Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container | Par Pharmaceutical, Inc. / a) 182,856 bottles; b) 59,448 bottles | Class II | Terminated |
| D-1045-2017 | 10-03-2016 | Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01 Package NDCs: 0143-1495-05; 0143-1495-01; 0143-1500-05; 0143-1500-01; 0143-1455-05; 0143-1455-01; 0143-1458-05; 0143-1458-01 | Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point | West-Ward Pharmaceuticals Corp. / N/A | Class II | Terminated |
| D-0008-2017 | 10-03-2016 | PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25. Package NDCs: 0054-4741-25; 0054-4741-31; 0054-4742-25; 0054-4728-25; 0054-4728-31; 0054-0017-25; 0054-0017-29; 0054-0017-20; 0054-0018-25; 0054-0018-29; 0054-0018-20; 0054-0019-20; 0054-0019-25; 0054-3722-63; 0054-3722-50; 0054-3721-44; 0054-8739-25; 0054-8740-25; 0054-8724-25 | Failed Tablet/Capsule Specifications: Discovery of an underweight tablet. | West-Ward Pharmaceutical / 15,109 bottles | Class II | Terminated |
| D-0009-2017 | 09-30-2016 | Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217. | Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities. | Amerisource Health Services / 648 cartons | Class III | Terminated |
| D-0136-2017 | 09-28-2016 | Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20 | Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 46,472 unit dose blister cards (10 cards of 10 tablets each) | Class III | Terminated |
| D-0135-2017 | 09-28-2016 | Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505 | Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 1,182 unit dose cards of 300 (10 punch cards of 30 tablets each) and 52,618 unit dose blister cards (10 cards of 10 tablets each) | Class III | Terminated |
| D-0123-2017 | 09-27-2016 | Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811 | Subpotent Drug; Ethinyl Estradiol | Par Pharmaceutical, Inc. / 44,127 tablets | Class III | Completed |
| D-0182-2017 | 09-27-2016 | Aid Backpack Kit - Product Code 85-0917, North American Rescue | Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. | North American Rescue LLC. / unknown | Class II | Terminated |
| D-0175-2017 | 09-27-2016 | Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue | Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. | North American Rescue LLC. / unknown | Class II | Terminated |
| D-0177-2017 | 09-27-2016 | Range Trauma Kit - Product Code 85-1274, North American Rescue | Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. | North American Rescue LLC. / unknown | Class II | Terminated |
| D-0178-2017 | 09-27-2016 | Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue | Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. | North American Rescue LLC. / unknown | Class II | Terminated |
| D-0179-2017 | 09-27-2016 | K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue | Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. | North American Rescue LLC. / unknown | Class II | Terminated |
| D-0183-2017 | 09-27-2016 | USCG Boat Response Kit - Product Code 80-0353, North American Rescue | Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. | North American Rescue LLC. / unknown | Class II | Terminated |
| D-0180-2017 | 09-27-2016 | Amphibious Trauma Kit - Product Code 85-0639, North American Rescue | Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. | North American Rescue LLC. / unknown | Class II | Terminated |
| D-0181-2017 | 09-27-2016 | Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue | Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. | North American Rescue LLC. / unknown | Class II | Terminated |
| D-0176-2017 | 09-27-2016 | Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue | Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. | North American Rescue LLC. / unknown | Class II | Terminated |
| D-0122-2017 | 09-27-2016 | Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811 | Subpotent Drug; Ethinyl Estradiol | Par Pharmaceutical, Inc. / 278,406 tablets | Class III | Completed |
| D-0119-2017 | 09-27-2016 | Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811 | Subpotent Drug; Ethinyl Estradiol | Par Pharmaceutical, Inc. / 221,017 tablets | Class III | Completed |
| D-0121-2017 | 09-27-2016 | Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811 | Subpotent Drug; Ethinyl Estradiol | Par Pharmaceutical, Inc. / 822,009 tablets | Class III | Completed |
| D-0120-2017 | 09-27-2016 | Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811 | Subpotent Drug; Ethinyl Estradiol | Par Pharmaceutical, Inc. / 393,981 tablets | Class III | Completed |
| D-0211-2017 | 09-23-2016 | Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only | Non-Sterility: failed sterility test result. | Guardian Pharmacy Services / 180 syringes | Class I | Terminated |
| D-0110-2017 | 09-22-2016 | PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56. | Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. | Teva Pharmaceuticals USA / 5,556 bottles | Class III | Terminated |
| D-0109-2017 | 09-22-2016 | PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56. | Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. | Teva Pharmaceuticals USA / 32,015 bottles | Class III | Terminated |
| D-0111-2017 | 09-22-2016 | PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56. | Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. | Teva Pharmaceuticals USA / 5,398 bottles | Class III | Terminated |
| D-0355-2017 | 09-21-2016 | DMSO (Dimethyl Sulfoxide) with Lidocaine 50%/0.5% mL Solution, 50 mL bottle, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 438 vials | Class II | Terminated |
| D-0408-2017 | 09-21-2016 | Tri 2 (PAP/PHEN/ATROPINE) NR Injectable, 30 mg/3 mg/0.3 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 238 vials and b) 607 vials | Class II | Terminated |
| D-0412-2017 | 09-21-2016 | Trimix Injectable 30 mg/2 mg/40 mcg, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 42 vials | Class II | Terminated |
| D-0330-2017 | 09-21-2016 | QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 1,312 vials and b) 3,354 vials | Class II | Terminated |
| D-0327-2017 | 09-21-2016 | Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 694 vials b) 389 vials c) 695 vials d) 5193 vials | Class II | Terminated |
| D-0415-2017 | 09-21-2016 | Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 9 vials and b) 78 vials, c) 210 vials | Class II | Terminated |
| D-0350-2017 | 09-21-2016 | Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 1,638 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0371-2017 | 09-21-2016 | MIC/BCOMP+CAR+ARG+CHR+LID 12.5 mg/25 mg/25 mg/25 mg/12.5 mg/0.2 mg/20 mg/mL Injectable, a) 10 mL and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 511 vials | Class II | Terminated |
| D-0332-2017 | 09-21-2016 | MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 308 vials | Class II | Terminated |
| D-0373-2017 | 09-21-2016 | MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 4 vials | Class II | Terminated |
| D-0421-2017 | 09-21-2016 | Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 335 vials | Class II | Terminated |
| D-0351-2017 | 09-21-2016 | Chorionic Gonadotropin Lyophilized, 20,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 908 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0401-2017 | 09-21-2016 | Testosterone Cypionate in Grapeseed Oil Injectable, 20 mg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 146 vials | Class II | Terminated |
| D-0368-2017 | 09-21-2016 | MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 633 vials | Class II | Terminated |
| D-0341-2017 | 09-21-2016 | Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network, LLC, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 30 vials | Class II | Terminated |
| D-0365-2017 | 09-21-2016 | Methylcobalamin 1,000 mcg/mL Injectable, a) 10 mL vial and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 499 vials b) 1214 vials | Class II | Terminated |
| D-0377-2017 | 09-21-2016 | Mitomycin Solution Injectable, Sterile 0.02%, 200 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 122 syringes | Class II | Terminated |
