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-1007-2019 | 01-16-2019 | Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10 | Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps. | Rx Pak Division of McKesson Corporation / 29,622 Blister Cards | Class II | Terminated |
| D-0389-2019 | 01-15-2019 | Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10 | Presence of Foreign Substance: Product complaint of black speckles observed on tablets. | Dr. Reddy's Laboratories, Inc. / 118 bottles | Class II | Terminated |
| D-0494-2019 | 01-15-2019 | infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24. | Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. | Tris Pharma Inc. / 35,328 bottles | Class II | Terminated |
| D-0495-2019 | 01-15-2019 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4. | Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. | Tris Pharma Inc. / 35,280 bottles | Class II | Terminated |
| D-0430-2019 | 01-15-2019 | HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syringe, Avella of Houston an FDA Registered 503B Outsourcing Facility 9265 Kirby Dr. Houston, TX 77054 (877) 794-0404 ---- NDC: 42852-725-65 | Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL) | Advanced Pharma Inc. / 160 syringes | Class II | Terminated |
| D-0390-2019 | 01-15-2019 | Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60. Package NDCs: 43386-069-60 | Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient. | LUPIN SOMERSET / 24,180 bottles | Class II | Terminated |
| D-0493-2019 | 01-15-2019 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23. | Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. | Tris Pharma Inc. / 46,080 bottles | Class II | Terminated |
| D-0492-2019 | 01-11-2019 | Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86 Package NDCs: 33342-321-86; 33342-321-39; 3334203218 | Defective Container; complaints of leakage. | Oxalis Labs / 53,358 bottles | Class III | Terminated |
| D-1466-2019 | 01-10-2019 | Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152. | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer | MAJOR PHARMACEUTICALS / 3,102 Cartons (310,200 tablets) | Class II | Terminated |
| D-0802-2020 | 01-10-2019 | Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704 | Presence of Particulate Matter: filmy/cloudy particulate observed in vial. | McGuff Compounding Pharmacy Services, Inc. / 146 30 ml vials were dispensed | Class II | Terminated |
| D-0423-2019 | 01-09-2019 | Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01 Package NDCs: 68180-123-01; 68180-123-02; 68180-124-01; 68180-124-02; 68180-440-01; 68180-440-02; 68180-441-01; 68180-441-02 | CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product. | Lupin Pharmaceuticals Inc. / 14,400 bottles | Class II | Terminated |
| D-0388-2019 | 01-08-2019 | 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644 | Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil | Happy Together, Inc. / N/A | Class I | Terminated |
| D-0380-2019 | 01-07-2019 | Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02 | CGMP Deviation; manufacturing batch record could not be located | Lupin Pharmaceuticals Inc. / 7,215 bottles | Class II | Terminated |
| D-0373-2019 | 01-03-2019 | Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC: 47335-932-40 [vial] 47335-932-44 [carton] Package NDCs: 47335-931-40; 47335-931-44; 47335-932-40; 47335-932-44 | Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection. | Sun Pharmaceutical Industries, Inc. / 1,384 cartons, 13,840 vials | Class I | Terminated |
| D-0372-2019 | 01-03-2019 | Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton] Package NDCs: 47335-931-40; 47335-931-44; 47335-932-40; 47335-932-44 | Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection. | Sun Pharmaceutical Industries, Inc. / 12,534 cartons, 125,340 vials | Class I | Terminated |
| D-0351-2019 | 01-02-2019 | Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52. Package NDCs: 0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0427-52; 0941-0427-53; 0941-0429-52; 0941-0429-53; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0484-01; 0941-0487-01; 0941-0490-01 | Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. | Baxter Healthcare Corporation / 29,370 bags | Class II | Terminated |
| D-0376-2019 | 01-02-2019 | Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. | Lupin Pharmaceuticals Inc. / 287,784 bottles | Class II | Terminated |
| D-0375-2019 | 01-02-2019 | Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. | Lupin Pharmaceuticals Inc. / 287,784 bottles | Class II | Terminated |
| D-0399-2019 | 01-02-2019 | MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 310 ml | Class II | Terminated |
| D-0406-2019 | 01-02-2019 | Cyclosporin liquid 0.05%, Rx, plastic dropper bottle | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / N/A | Class II | Terminated |
| D-0402-2019 | 01-02-2019 | Vitamin B12 liquid 1000mcg/ml, RX, glass vial | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 150 ml | Class II | Terminated |
| D-0404-2019 | 01-02-2019 | Cyclosporin liquid 0.5%, Rx, plastic dropper bottle | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / N/A | Class II | Terminated |
| D-0395-2019 | 01-02-2019 | HCG liquid, 1000u/ml, RX, glass vial, various | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 30 ml | Class II | Terminated |
| D-0393-2019 | 01-02-2019 | Epinephrine liquid 1:1000, RX, glass vial | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 50 ml | Class II | Terminated |
| D-0394-2019 | 01-02-2019 | Glutathione liquid, 100mg/ml | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 60 ml | Class II | Terminated |
| D-0400-2019 | 01-02-2019 | Methocarbamol liquid 100mg/ml, RX, glass vial | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 300 ml | Class II | Terminated |
| D-0397-2019 | 01-02-2019 | Lidocaine gel 2%, RX, plastic dropper | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 125 ml | Class II | Terminated |
| D-0403-2019 | 01-02-2019 | Cyclosporin liquid 1%, Rx, plastic dropper bottle | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / N/A | Class II | Terminated |
| D-0408-2019 | 01-02-2019 | Lidocaine gel 1%, RX, plastic dropper | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / N/A | Class II | Terminated |
| D-0392-2019 | 01-02-2019 | Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 830 ml | Class II | Terminated |
| D-0405-2019 | 01-02-2019 | Cyclosporin liquid 0.2%, Rx, plastic dropper bottle | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / N/A | Class II | Terminated |
| D-0401-2019 | 01-02-2019 | Testosteron Cypionate liquid 200mg/ml, RX, glass vial | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 200 ml | Class II | Terminated |
| D-0398-2019 | 01-02-2019 | Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 50 ml | Class II | Terminated |
| D-0407-2019 | 01-02-2019 | Glutathione liquid, 200mg/ml, Rx | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / N/A | Class II | Terminated |
| D-0396-2019 | 01-02-2019 | Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial | Lack of sterility assurance. | Hiers Enterprises, LLC dba Northwest Compounding Pharmacy / 20 ml | Class II | Terminated |
| D-0352-2019 | 01-02-2019 | Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31 | Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle | Heritage Pharmaceuticals, Inc. / 5,060 units | Class II | Terminated |
| D-0374-2019 | 01-02-2019 | 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478. | Subpotent | PharMEDium Services, LLC. / 7,711 syringes | Class II | Terminated |
| D-1037-2019 | 12-31-2018 | Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30 Package NDCs: 65862-570-30; 65862-570-99; 65862-570-10; 65862-571-90; 65862-571-99; 65862-571-10; 65862-572-90; 65862-572-99; 65862-572-10; 65862-573-90; 65862-573-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Aurobindo Pharma USA Inc. / N/A | Class II | Ongoing |
| D-1035-2019 | 12-31-2018 | Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90 Package NDCs: 65862-570-30; 65862-570-99; 65862-570-10; 65862-571-90; 65862-571-99; 65862-571-10; 65862-572-90; 65862-572-99; 65862-572-10; 65862-573-90; 65862-573-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Aurobindo Pharma USA Inc. / N/A | Class II | Ongoing |
| D-1038-2019 | 12-31-2018 | Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90 Package NDCs: 65862-570-30; 65862-570-99; 65862-570-10; 65862-571-90; 65862-571-99; 65862-571-10; 65862-572-90; 65862-572-99; 65862-572-10; 65862-573-90; 65862-573-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Aurobindo Pharma USA Inc. / N/A | Class II | Ongoing |
| D-0370-2019 | 12-31-2018 | Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90. Package NDCs: 65862-570-30; 65862-570-99; 65862-570-10; 65862-571-90; 65862-571-99; 65862-571-10; 65862-572-90; 65862-572-99; 65862-572-10; 65862-573-90; 65862-573-05 | 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. | Aurobindo Pharma USA Inc. / 20,604 bottles | Class II | Ongoing |
| D-1039-2019 | 12-31-2018 | Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90 Package NDCs: 65862-570-30; 65862-570-99; 65862-570-10; 65862-571-90; 65862-571-99; 65862-571-10; 65862-572-90; 65862-572-99; 65862-572-10; 65862-573-90; 65862-573-05 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Aurobindo Pharma USA Inc. / N/A | Class II | Ongoing |
| D-0364-2019 | 12-31-2018 | Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30. Package NDCs: 65862-737-30; 65862-737-90; 65862-737-10; 65862-737-03; 65862-739-30; 65862-739-90; 65862-739-10; 65862-739-03; 65862-738-30; 65862-738-90; 65862-738-10; 65862-738-03; 65862-740-30; 65862-740-90; 65862-740-10; 65862-740-03 | 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. | Aurobindo Pharma USA Inc. / 55,788 bottles | Class II | Ongoing |
| D-0368-2019 | 12-31-2018 | Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90. Package NDCs: 65862-547-90; 65862-547-99; 65862-547-10; 65862-548-90; 65862-548-99; 65862-548-10; 65862-549-90; 65862-549-99; 65862-549-10; 65862-550-90; 65862-550-05; 65862-551-90; 65862-551-05 | 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. | Aurobindo Pharma USA Inc. / 32,160 bottles | Class II | Ongoing |
| D-0362-2019 | 12-31-2018 | Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30. Package NDCs: 65862-737-30; 65862-737-90; 65862-737-10; 65862-737-03; 65862-739-30; 65862-739-90; 65862-739-10; 65862-739-03; 65862-738-30; 65862-738-90; 65862-738-10; 65862-738-03; 65862-740-30; 65862-740-90; 65862-740-10; 65862-740-03 | 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. | Aurobindo Pharma USA Inc. / 60,417 bottles | Class II | Ongoing |
| D-1036-2019 | 12-31-2018 | Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30 Package NDCs: 65862-737-30; 65862-737-90; 65862-737-10; 65862-737-03; 65862-739-30; 65862-739-90; 65862-739-10; 65862-739-03; 65862-738-30; 65862-738-90; 65862-738-10; 65862-738-03; 65862-740-30; 65862-740-90; 65862-740-10; 65862-740-03 | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Aurobindo Pharma USA Inc. / N/A | Class II | Ongoing |
| D-0366-2019 | 12-31-2018 | Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90. Package NDCs: 65862-547-90; 65862-547-99; 65862-547-10; 65862-548-90; 65862-548-99; 65862-548-10; 65862-549-90; 65862-549-99; 65862-549-10; 65862-550-90; 65862-550-05; 65862-551-90; 65862-551-05 | 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. | Aurobindo Pharma USA Inc. / 92,616 bottles | Class II | Ongoing |
| D-0369-2019 | 12-31-2018 | Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90. Package NDCs: 65862-547-90; 65862-547-99; 65862-547-10; 65862-548-90; 65862-548-99; 65862-548-10; 65862-549-90; 65862-549-99; 65862-549-10; 65862-550-90; 65862-550-05; 65862-551-90; 65862-551-05 | 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. | Aurobindo Pharma USA Inc. / 53,064 bottles | Class II | Ongoing |
| D-0367-2019 | 12-31-2018 | Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90. Package NDCs: 65862-547-90; 65862-547-99; 65862-547-10; 65862-548-90; 65862-548-99; 65862-548-10; 65862-549-90; 65862-549-99; 65862-549-10; 65862-550-90; 65862-550-05; 65862-551-90; 65862-551-05 | 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. | Aurobindo Pharma USA Inc. / 111,239 bottles | Class II | Ongoing |
| D-0363-2019 | 12-31-2018 | Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30. Package NDCs: 65862-737-30; 65862-737-90; 65862-737-10; 65862-737-03; 65862-739-30; 65862-739-90; 65862-739-10; 65862-739-03; 65862-738-30; 65862-738-90; 65862-738-10; 65862-738-03; 65862-740-30; 65862-740-90; 65862-740-10; 65862-740-03 | 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. | Aurobindo Pharma USA Inc. / 27,688 bottles | Class II | Ongoing |
| D-0365-2019 | 12-31-2018 | Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90. Package NDCs: 65862-547-90; 65862-547-99; 65862-547-10; 65862-548-90; 65862-548-99; 65862-548-10; 65862-549-90; 65862-549-99; 65862-549-10; 65862-550-90; 65862-550-05; 65862-551-90; 65862-551-05 | 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. | Aurobindo Pharma USA Inc. / 23,016 bottles | Class II | Ongoing |
| D-0361-2019 | 12-31-2018 | Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30 Package NDCs: 65862-737-30; 65862-737-90; 65862-737-10; 65862-737-03; 65862-739-30; 65862-739-90; 65862-739-10; 65862-739-03; 65862-738-30; 65862-738-90; 65862-738-10; 65862-738-03; 65862-740-30; 65862-740-90; 65862-740-10; 65862-740-03 | 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. | Aurobindo Pharma USA Inc. / 18,408 bottles | Class II | Ongoing |
| D-0350-2019 | 12-26-2018 | Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ Package NDCs: 68462-711-71; 68462-711-88 | Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator | Glenmark Pharmaceuticals Inc., USA / 96,240 applicators | Class II | Terminated |
| D-0391-2019 | 12-26-2018 | LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256 Ohm Laboratories Inc. UPC 0 93351 11270 6 NDC#:53943-123-24 Package NDCs: 53943-123-12; 53943-123-24 | Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets. | Sun Pharmaceutical Industries, Inc. / 5040 cartons | Class III | Terminated |
| D-0346-2019 | 12-21-2018 | Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11. Package NDCs: 43386-450-11 | Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay. | LUPIN SOMERSET / 23,460 bottles | Class II | Terminated |
| D-0483-2019 | 12-20-2018 | COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10 | Failed Stability Specifications: out of specification results for opalescence at 7 month stability study. | Akorn Inc / 30,794 bottles | Class III | Terminated |
| D-0504-2019 | 12-20-2018 | LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), 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. / 18,852 bottles | Class II | Ongoing |
| D-0505-2019 | 12-20-2018 | LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), 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. / 18,780 bottles | Class II | Ongoing |
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
