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-0387-2019 | 12-20-2018 | OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07 Package NDCs: 0023-3348-07; 0023-3348-08 | GMP Deviations: A silicone particulate was noted in Ozurdex. | Allergan, PLC. / 133,716 Cartons | Class II | Completed |
| D-0358-2019 | 12-20-2018 | Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10. | Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials. | Lupin Pharmaceuticals Inc. / 3,792 boxes | Class I | Terminated |
| D-0355-2019 | 12-20-2018 | Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA. | Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials. | Lupin Pharmaceuticals Inc. / a) 12,000 vials; b) 11,763 boxes | Class I | Terminated |
| D-0344-2019 | 12-20-2018 | Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ | Failed Dissolution Specifications | Amerigen Pharmaceuticals Inc. / 3552 bottles | Class III | Terminated |
| D-0345-2019 | 12-20-2018 | Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14 | Failed Dissolution Specifications | Amerigen Pharmaceuticals Inc. / 771 bottles | Class III | Terminated |
| D-0503-2019 | 12-20-2018 | LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Torrent Pharma Inc. / 43,416 bottles | Class II | Ongoing |
| D-0356-2019 | 12-20-2018 | Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA. | Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials. | Lupin Pharmaceuticals Inc. / a) 8,000 vials; b) 32,045 boxes | Class I | Terminated |
| D-0357-2019 | 12-20-2018 | Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA. | Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials. | Lupin Pharmaceuticals Inc. / a) 35,000 vials; b) 112,641 boxes | Class I | Terminated |
| D-0502-2019 | 12-20-2018 | LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Torrent Pharma Inc. / 65,832 bottles | Class II | Ongoing |
| D-0501-2019 | 12-20-2018 | LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Torrent Pharma Inc. / 83,016 bottles | Class II | Ongoing |
| D-0381-2019 | 12-19-2018 | Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Pharmaceutical USA, INC., North Wales, PA 19454 | Failed dissolution specifications | Teva Pharmaceuticals USA / 181,456 bottles | Class II | Terminated |
| D-1002-2019 | 12-19-2018 | Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875 | CGMP Deviations | Roberts Home Medical LLC / 9 Reservoirs | Class II | Terminated |
| D-0486-2019 | 12-18-2018 | CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, Fushi Rd., Haidian, Beijing 100049, China. Batch Number JD-BP-37-20150801 | CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | LGM Pharma LLC / 205 grams | Class II | Terminated |
| D-0449-2019 | 12-17-2018 | Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 255 vials | Class II | Terminated |
| D-0460-2019 | 12-17-2018 | HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 654 vials | Class II | Terminated |
| D-0442-2019 | 12-17-2018 | Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 252 vials | Class II | Terminated |
| D-0417-2019 | 12-17-2018 | Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0002-99 | Lack of Processing Controls. | Duren Health Mart Pharmacy / 200 grams | Class II | Terminated |
| D-0456-2019 | 12-17-2018 | IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 59 vials | Class II | Terminated |
| D-0436-2019 | 12-17-2018 | Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 900 3 ml bottles | Class II | Terminated |
| D-0472-2019 | 12-17-2018 | Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 5 10ml vials | Class II | Terminated |
| D-0462-2019 | 12-17-2018 | HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 819 vials | Class II | Terminated |
| D-0452-2019 | 12-17-2018 | Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 927 vials | Class II | Terminated |
| D-0461-2019 | 12-17-2018 | HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 2595 vials | Class II | Terminated |
| D-0440-2019 | 12-17-2018 | Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 210 5 ml vials | Class II | Terminated |
| D-0443-2019 | 12-17-2018 | Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 704 vials | Class II | Terminated |
| D-0476-2019 | 12-17-2018 | Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 15 10ml vials | Class II | Terminated |
| D-0416-2019 | 12-17-2018 | Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-07 | Lack of Processing Controls. | Duren Health Mart Pharmacy / 2700 cc | Class II | Terminated |
| D-0467-2019 | 12-17-2018 | MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10mL, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 64 vials | Class II | Terminated |
| D-0459-2019 | 12-17-2018 | BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 37 vials | Class II | Terminated |
| D-0446-2019 | 12-17-2018 | Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 196 50 ml vials | Class II | Terminated |
| D-0474-2019 | 12-17-2018 | Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 11 10ml vials | Class II | Terminated |
| D-0450-2019 | 12-17-2018 | Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 341 vials | Class II | Terminated |
| D-0434-2019 | 12-17-2018 | Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 250 3 ml bottles | Class II | Terminated |
| D-0444-2019 | 12-17-2018 | Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 158 10 ml vials | Class II | Terminated |
| D-0454-2019 | 12-17-2018 | Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 139 vials | Class II | Terminated |
| D-0441-2019 | 12-17-2018 | Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromium 25 mg/50 mg/50 mg/25 mg/2.5 mg/25 mg/2 mg/25 mg/0.5 mg2.5 mg/1.33 mcg/mL injection 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 158 10 ml vials | Class II | Terminated |
| D-0465-2019 | 12-17-2018 | Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 43 vials | Class II | Terminated |
| D-0419-2019 | 12-17-2018 | Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03 | Lack of Processing Controls. | Duren Health Mart Pharmacy / 876 cc | Class II | Terminated |
| D-0481-2019 | 12-17-2018 | Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 1 10 ml vial | Class II | Terminated |
| D-0473-2019 | 12-17-2018 | Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 7 10 ml vials | Class II | Terminated |
| D-0445-2019 | 12-17-2018 | Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 288 10 ml vials | Class II | Terminated |
| D-0448-2019 | 12-17-2018 | Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 25 vials | Class II | Terminated |
| D-0447-2019 | 12-17-2018 | Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 94 vials | Class II | Terminated |
| D-0458-2019 | 12-17-2018 | Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 64 vials | Class II | Terminated |
| D-0468-2019 | 12-17-2018 | Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 5 10 mL vials | Class II | Terminated |
| D-0469-2019 | 12-17-2018 | Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 1 vial | Class II | Terminated |
| D-0478-2019 | 12-17-2018 | Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 7 vials | Class II | Terminated |
| D-0455-2019 | 12-17-2018 | Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 93 vials | Class II | Terminated |
| D-0475-2019 | 12-17-2018 | Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 8 10ml vials | Class II | Terminated |
| D-0431-2019 | 12-17-2018 | Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684. | Lack of sterility assurance. | Promise Pharmacy, LLC / 75 10 ml bottles | Class II | Terminated |
| D-0421-2019 | 12-17-2018 | Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00507-2011-00 | Lack of Processing Controls. | Duren Health Mart Pharmacy / 840 capsules | Class II | Terminated |
| D-0420-2019 | 12-17-2018 | Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00311-2003-01 | Lack of Processing Controls. | Duren Health Mart Pharmacy / 1306 capsules | Class II | Terminated |
| D-0435-2019 | 12-17-2018 | Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 2057 6 ml bottles | Class II | Terminated |
| D-0479-2019 | 12-17-2018 | Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 2 10ml vials | Class II | Terminated |
| D-0438-2019 | 12-17-2018 | Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US Hwy 19N, Palm Harbor FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 204 10 ml vials | Class II | Terminated |
| D-0477-2019 | 12-17-2018 | Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 11 10 ml vials | Class II | Terminated |
| D-0439-2019 | 12-17-2018 | Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 3 30 ml vials | Class II | Terminated |
| D-0457-2019 | 12-17-2018 | Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 30 vials | Class II | Terminated |
| D-0453-2019 | 12-17-2018 | Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 416 vials | Class II | Terminated |
| D-0451-2019 | 12-17-2018 | Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 296 vials | Class II | Terminated |
| D-0471-2019 | 12-17-2018 | Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 2 10 ml vials | Class II | Terminated |
| D-0437-2019 | 12-17-2018 | Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 167 3 ml bottles | Class II | Terminated |
| D-0463-2019 | 12-17-2018 | Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 266 vials | Class II | Terminated |
| D-0418-2019 | 12-17-2018 | Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00000-0000-98 | Lack of Processing Controls. | Duren Health Mart Pharmacy / 300 grams | Class II | Terminated |
| D-0480-2019 | 12-17-2018 | Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 3 | Class II | Terminated |
| D-0466-2019 | 12-17-2018 | ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 846 vials | Class II | Terminated |
| D-0464-2019 | 12-17-2018 | IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 59 vials | Class II | Terminated |
| D-0432-2019 | 12-17-2018 | Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 43 3 mL bottles | Class II | Terminated |
| D-0470-2019 | 12-17-2018 | Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic Acid/Hydroxycobalamin/Magnesium Chloride, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 5 vials | Class II | Terminated |
| D-0433-2019 | 12-17-2018 | Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684 | Lack of sterility assurance. | Promise Pharmacy, LLC / 55 3 ml bottles | Class II | Terminated |
| D-0382-2019 | 12-14-2018 | Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02 | Failed Dissolution Specifications. | Cipla Limited / 4800 bottles | Class II | Terminated |
| D-0360-2019 | 12-14-2018 | Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4 | Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver | Results RNA, LLC / 10,297 bottles | Class I | Terminated |
| D-0353-2019 | 12-11-2018 | Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01 | Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex | Asclemed USA Inc. dba Enovachem / | Class I | Terminated |
| D-0354-2019 | 12-11-2018 | Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01 | Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex | Asclemed USA Inc. dba Enovachem / | Class I | Terminated |
| D-0340-2019 | 12-11-2018 | Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50 Package NDCs: 10702-201-01; 10702-201-50; 10702-201-10 | Labeling: Wrong bar code | KVK-Tech, Inc. / 156 bottles | Class II | Terminated |
| D-0294-2019 | 12-10-2018 | Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31 Package NDCs: 55111-671-30; 55111-671-90; 55111-671-01; 55111-671-05; 55111-671-48; 55111-671-79; 55111-671-81; 55111-671-06; 55111-671-31; 55111-671-78 | Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing. | Dr. Reddy's Laboratories, Inc. / 4,404 (30 count blister packs) | Class II | Terminated |
| D-0341-2019 | 12-10-2018 | Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube. | Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. | CBI Laboratories, Inc. / 5363 tubes | Class III | Terminated |
| D-0338-2019 | 12-10-2018 | Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8. | Superpotent Drug: contains higher levels of Iron than labeled. | Gordon Laboratories / 1,155 boxes | Class II | Terminated |
| D-0342-2019 | 12-10-2018 | Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort Worth, TX 76155 | Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. | CBI Laboratories, Inc. / 2055 tubes | Class III | Terminated |
| D-0425-2019 | 12-07-2018 | Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22 | GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample | US Pharmaceuticals Inc. / 19752 units | Class II | Terminated |
| D-0427-2019 | 12-07-2018 | Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060. | GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample | US Pharmaceuticals Inc. / 7020 units | Class II | Terminated |
| D-0426-2019 | 12-07-2018 | Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03 Package NDCs: 0363-0237-02; 0363-0237-03 | GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample | US Pharmaceuticals Inc. / 67848 units | Class II | Terminated |
| D-1207-2019 | 12-07-2018 | Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack) Package NDCs: 10631-115-69; 10631-115-31; 10631-116-69; 10631-116-31; 10631-117-69; 10631-117-31; 10631-118-69; 10631-118-31; 10631-133-69; 10631-133-31; 10631-134-69; 10631-134-31; 10631-002-31; 10631-003-31; 10631-004-31; 10631-005-31; 10631-006-31; 10631-007-31; 3106311173 | Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring. | Sun Pharmaceutical Industries, Inc. / 47,520 prescription packs | Class III | Terminated |
| D-0339-2019 | 12-06-2018 | Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-01 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 Drug. | Pfizer Inc. / 1996 bottles | Class II | Terminated |
| D-0333-2019 | 12-05-2018 | Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75. | Sub-potent | Pharmedium Services, LLC / 295 50 ml in 60 ml syringes | Class II | Terminated |
| D-0334-2019 | 12-05-2018 | Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48 | Sub-potent | Pharmedium Services, LLC / 295 100 mL in 150 mL Intravia bags | Class II | Terminated |
| D-0326-2019 | 12-04-2018 | Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 232,180 HDPE bottles | Class II | Ongoing |
| D-0328-2019 | 12-04-2018 | Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 32,696 HDPE bottles | Class II | Ongoing |
| D-0332-2019 | 12-04-2018 | Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 32,284 HDPE bottles | Class II | Ongoing |
| D-0322-2019 | 12-04-2018 | Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 109,314 HDPE bottles | Class II | Ongoing |
| D-0327-2019 | 12-04-2018 | Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 129,754 HDPE bottles | Class II | Ongoing |
| D-0321-2019 | 12-04-2018 | Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1722-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 76,516 HDPE bottles | Class II | Ongoing |
| D-0325-2019 | 12-04-2018 | Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 119,761 HDPE bottles | Class II | Ongoing |
| D-0323-2019 | 12-04-2018 | Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 84,066 HDPE bottles | Class II | Ongoing |
| D-0297-2019 | 12-04-2018 | Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01 | Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets. | Epic Pharma, LLC / 2976 bottles | Class II | Terminated |
| D-0320-2019 | 12-04-2018 | Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93. Package NDCs: 0378-1721-93; 0378-1722-93; 0378-1723-93; 0378-1724-93 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 141,995 HDPE bottles | Class II | Ongoing |
| D-0329-2019 | 12-04-2018 | Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 50,595 HDPE bottles | Class II | Ongoing |
| D-0331-2019 | 12-04-2018 | Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 19,352 HDPE bottles | Class II | Ongoing |
| D-0330-2019 | 12-04-2018 | Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Package NDCs: 0378-6321-77; 0378-6321-05; 0378-6322-77; 0378-6322-05; 0378-6323-77; 0378-6323-05; 0378-6324-77; 0378-6324-05; 0378-6325-77; 0378-6325-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 22,813 HDPE bottles | Class II | Ongoing |
| D-0324-2019 | 12-04-2018 | Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Mylan Laboratories Limited, (Nashik FDF) / 160,300 HDPE bottles | Class II | Ongoing |
