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 July 04, 2025 and include a total of 16930 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1204-2018 | 09-11-2018 | Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30 Package NDCs: 13668-339-30; 13668-339-01; 13668-339-05; 13668-340-30; 13668-340-01; 13668-340-05; 13668-341-30; 13668-341-01; 13668-341-05; 13668-342-30; 13668-342-01 | Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing. | Torrent Pharma Inc. / 15,384 30-count bottles | Class II | Terminated |
| D-0177-2019 | 09-10-2018 | QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1342-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 25 milliliters | Class II | Terminated |
| D-0162-2019 | 09-10-2018 | HCG 4000 Unit Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1704-01 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 2737 vials | Class II | Terminated |
| D-0201-2019 | 09-10-2018 | Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1367-02 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 430 vials | Class II | Terminated |
| D-0188-2019 | 09-10-2018 | Sterile Water 50 mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1421-50 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 10 bags | Class II | Terminated |
| D-0176-2019 | 09-10-2018 | Pyridoxine 100 mg/mL, 30 mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1614-30 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 600 milliliters | Class II | Terminated |
| D-0199-2019 | 09-10-2018 | Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1365-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 715 vials | Class II | Terminated |
| D-0145-2019 | 09-10-2018 | Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1428-02 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 567 milliliters | Class II | Terminated |
| D-0172-2019 | 09-10-2018 | Phosphate Buffer Solution 0.05 m Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-0912-20 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 1900 milliliters | Class II | Terminated |
| D-0167-2019 | 09-10-2018 | Magnesium 40 gm/ns 1000 mL IV, Pharm D Solutions, Houston, Texas --- NDC 69699-0904-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 4 vials | Class II | Terminated |
| D-0200-2019 | 09-10-2018 | Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1366-02 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 815 vials | Class II | Terminated |
| D-0186-2019 | 09-10-2018 | Slenderella Compound Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-30 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 5000 milliliters | Class II | Terminated |
| D-0214-2019 | 09-10-2018 | Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1745-30 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 580 vials and 30000 milliliters | Class II | Terminated |
| D-0150-2019 | 09-10-2018 | Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 69699-1610-30 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 2000 milliliters | Class II | Terminated |
| D-0174-2019 | 09-10-2018 | Prostaglandin E1 40 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1347-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 154 milliliters | Class II | Terminated |
| D-0139-2019 | 09-10-2018 | Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1611-30 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 6000 milliliters | Class II | Terminated |
| D-0151-2019 | 09-10-2018 | Epi-Shugarcaine Kit Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1409-60 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 70 bottles | Class II | Terminated |
| D-0173-2019 | 09-10-2018 | Prostaglandin E1 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1623-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 193 milliliters | Class II | Terminated |
| D-0168-2019 | 09-10-2018 | Methylcobalamin 1 mg/mL a) 10 mL Injectable NDC 69699-1501-10; b) 30 mL Injectable NDC 69699-1501-30, Pharm D Solutions, Houston, Texas | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 24500 milliliters | Class II | Terminated |
| D-0206-2019 | 09-10-2018 | Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1311-03 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 336 milliliters | Class II | Terminated |
| D-0148-2019 | 09-10-2018 | Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-0914-30 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 6850 milliliters | Class II | Terminated |
| D-0190-2019 | 09-10-2018 | Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, Houston, Texas | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 553 vials | Class II | Terminated |
| D-0195-2019 | 09-10-2018 | Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1336-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 20 milliliters | Class II | Terminated |
| D-0153-2019 | 09-10-2018 | Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas ---- NDC 69699-1439-59 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 1095 milliliters | Class II | Terminated |
| D-0141-2019 | 09-10-2018 | Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 130 milliliters | Class II | Terminated |
| D-0170-2019 | 09-10-2018 | Phenol 5% and Glycerin Aqueous Solution 10 mL Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1431-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 1139 milliliters | Class II | Terminated |
| D-0203-2019 | 09-10-2018 | Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1388-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 40 milliliters | Class II | Terminated |
| D-0194-2019 | 09-10-2018 | Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1352-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 9 vials | Class II | Terminated |
| D-0137-2019 | 09-10-2018 | Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 7150 milliliters | Class II | Terminated |
| D-0191-2019 | 09-10-2018 | Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D Solutions, Houston, Texas | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 609 vials | Class II | Terminated |
| D-0169-2019 | 09-10-2018 | Oxytocin 30 unit in LR 500 mL 0.06 units/mL IV,Pharm D Solutions, Houston, Texas --- NDC 69699-1203-50 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 264 vials | Class II | Terminated |
| D-0138-2019 | 09-10-2018 | Ascorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1502-50 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 10000 milliliters | Class II | Terminated |
| D-0207-2019 | 09-10-2018 | Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65 mg/Phentolamine 0.59 mcg per mL Pharm D Solutions, Houston, Texas --- NDC 69699-1366-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 10 milliliters | Class II | Terminated |
| D-0159-2019 | 09-10-2018 | HCG 10,000 unit/0.3 gm Mannitol Lyopholized, Pharm D Solutions, Houston, Texas ---- NDC 69699-1711-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 1171 vials | Class II | Terminated |
| D-0205-2019 | 09-10-2018 | Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1308-03 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 343 milliliters | Class II | Terminated |
| D-0198-2019 | 09-10-2018 | Trimix AT-6 Papa 30 mg/Phent 4 mg/Atrop. 0.3 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1343-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 40 milliliters | Class II | Terminated |
| D-0144-2019 | 09-10-2018 | Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO) Powder NDC 69699-1760-15, Pharm D Solutions, Houston, Texas | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 29 vials | Class II | Terminated |
| D-0160-2019 | 09-10-2018 | HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1743-12 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 881 vials | Class II | Terminated |
| D-0140-2019 | 09-10-2018 | Bacteriostatic Water for Injection 10 mL, Pharm D Solutions, Houston, Texas --- NDC 69699-1417-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 285 vials | Class II | Terminated |
| D-0142-2019 | 09-10-2018 | Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1305-03 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 148 milliliters | Class II | Terminated |
| D-0181-2019 | 09-10-2018 | Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1748-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 124 vials | Class II | Terminated |
| D-0149-2019 | 09-10-2018 | Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebulization Solution 2.5% Inhal. Soln NDC 69699-0908-10; d) Nebulization 250 mL 2.5% Inhal Soln NDC 69699-0908-25; e) Oral Spray 2.5% 2.5% Oral Soln NDC 69699-0917-60, Pharm D Solutions, Houston, Texas | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 57 bottles; 2300 milliliters | Class III | Terminated |
| D-0204-2019 | 09-10-2018 | Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1344-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 59 milliliters | Class II | Terminated |
| D-0136-2019 | 09-10-2018 | Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 486 milliliters | Class II | Terminated |
| D-0164-2019 | 09-10-2018 | HCG 6000 unit/0.3 gm Mannitol Lyopholized 6000 IU/vial injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1739-06 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 442 vials | Class II | Terminated |
| D-0178-2019 | 09-10-2018 | Reck Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1459-50 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 517 syringes | Class II | Terminated |
| D-0189-2019 | 09-10-2018 | Tilarginine Acetate 50 mg/mL, 10 mL, Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1461-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 3523 milliliters | Class II | Terminated |
| D-0158-2019 | 09-10-2018 | HCG Reconstitued 6000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1739-06 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 10 vials | Class II | Terminated |
| D-0210-2019 | 09-10-2018 | Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 521 syringes | Class II | Terminated |
| D-0196-2019 | 09-10-2018 | Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1319-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 50 milliliters | Class II | Terminated |
| D-0187-2019 | 09-10-2018 | 0.9% Sodium Chloride for Injection, 50 mL bags, Pharm D Solutions, Houston, Texas --- NDC 69699-1426-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 12 bags | Class II | Terminated |
| D-0175-2019 | 09-10-2018 | Prostaglandin E1 80 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1337-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 189 milliliters | Class II | Terminated |
| D-0193-2019 | 09-10-2018 | Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1354-03 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 20 milliliters | Class II | Terminated |
| D-0155-2019 | 09-10-2018 | Glycerin 72% (Lidocaine/Epi 2:1) Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1401-30 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 180 milliliters | Class II | Terminated |
| D-0163-2019 | 09-10-2018 | HCG 50,000 unit/0.3 gm Mannitol Lyophilized Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 114 vials | Class II | Terminated |
| D-0147-2019 | 09-10-2018 | Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0906-12 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 29 bottles | Class II | Terminated |
| D-0197-2019 | 09-10-2018 | Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1330-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 65 milliliters | Class II | Terminated |
| D-0184-2019 | 09-10-2018 | Sermorelin/GHRP-2/GHRP-6 Mannitol 9 mg/9 mg/9 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1726-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 420 vials | Class II | Terminated |
| D-0166-2019 | 09-10-2018 | Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution Compound Injectable NDC 69699-1603-30, Pharm D Solutions, Houston, Texas | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 896 vials; 64000 milliliters | Class II | Terminated |
| D-0152-2019 | 09-10-2018 | Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-0109-03 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 945 syringes | Class II | Terminated |
| D-0161-2019 | 09-10-2018 | HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 765 vials | Class II | Terminated |
| D-0185-2019 | 09-10-2018 | Sermorelin/GHRP-2/Theanine/Mannitol 15 mg/6 mg/75 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1731-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 108 vials | Class II | Terminated |
| D-0182-2019 | 09-10-2018 | Sermorelin/GHRP-2 9 mg-6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1728-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 330 vials | Class II | Terminated |
| D-0171-2019 | 09-10-2018 | Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1432-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 630 milliliters | Class II | Terminated |
| D-0213-2019 | 09-10-2018 | Testosterone in Grapeseed Oil 200 mg/mL, a) 4 mL, b) 5 mL, c) 10 mL and d) 30 mL Injectable, Pharm D Solutions, Houston, Texas NDC 69699-1702-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / a) 4397, b) 4885 c) 1319, d) 4112 vials | Class II | Terminated |
| D-0192-2019 | 09-10-2018 | Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1310-03 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 67 milliliters | Class II | Terminated |
| D-0143-2019 | 09-10-2018 | Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1317-03 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 115 milliliters | Class II | Terminated |
| D-0179-2019 | 09-10-2018 | Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1759-18 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 179 vials | Class II | Terminated |
| D-0146-2019 | 09-10-2018 | Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0907-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 25 bottles | Class II | Terminated |
| D-0183-2019 | 09-10-2018 | Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1715-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 250 vials | Class II | Terminated |
| D-0156-2019 | 09-10-2018 | HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1707-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 2219 vials | Class II | Terminated |
| D-0211-2019 | 09-10-2018 | Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- NDC 69699-1407-25 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 12 bags | Class II | Terminated |
| D-0157-2019 | 09-10-2018 | HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 3 vials | Class II | Terminated |
| D-0212-2019 | 09-10-2018 | Zinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1418-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 184 vials | Class II | Terminated |
| D-0165-2019 | 09-10-2018 | Levocarnitine 170 mg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 3000 milliliters | Class II | Terminated |
| D-0180-2019 | 09-10-2018 | Sermorelin/GHRP-2 6 mg/6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1727-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 409 vials | Class II | Terminated |
| D-0026-2019 | 09-10-2018 | Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30 | Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets. | Takeda Development Center Americas, Inc. / 7,248 bottles | Class II | Terminated |
| D-0209-2019 | 09-10-2018 | Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions, Houston, Texas --- NDC 69699-1351-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 40 milliliters | Class II | Terminated |
| D-0154-2019 | 09-10-2018 | Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1504-30 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 4000 milliliters | Class II | Terminated |
| D-0208-2019 | 09-10-2018 | Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1339-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 44 milliliters | Class II | Terminated |
| D-0202-2019 | 09-10-2018 | Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1369-02 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 195 vials | Class II | Terminated |
| D-1207-2018 | 09-07-2018 | Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8 Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. / 213714 boxes of 8 patches and 15927 boxes of 2 patches | Class II | Terminated |
| D-1210-2018 | 09-07-2018 | Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8 Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. / 74908 boxes of 8 patches | Class II | Terminated |
| D-1208-2018 | 09-07-2018 | Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8 Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. / 149631 boxes of 8 patches and 15809 boxes of 2 patches | Class II | Terminated |
| D-1209-2018 | 09-07-2018 | Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8 Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. / 26217 boxes of 8 patches | Class II | Terminated |
| D-1212-2018 | 09-06-2018 | Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Package NDCs: 69097-875-02; 69097-875-05; 69097-875-12; 69097-876-02; 69097-876-12; 68001-322-05 | Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size. | InvaGen Pharmaceuticals, Inc. / 26,496 bottles | Class III | Terminated |
| D-1185-2018 | 09-06-2018 | Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11 | Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels. | Par Pharmaceutical, Inc. / 16,207 (bottles of 30 tablets) | Class III | Terminated |
| D-1190-2018 | 09-06-2018 | 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | cGMP Deviation | Baxter Healthcare Corporation / 5184 bags | Class II | Terminated |
| D-1217-2018 | 09-04-2018 | Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC 0597-0175-18 Package NDCs: 0597-0159-60; 0597-0159-18; 0597-0159-66; 0597-0175-60; 0597-0175-18; 0597-0175-66; 0597-0180-60; 0597-0180-18; 0597-0180-66; 0597-0168-60; 0597-0168-18; 0597-0168-66 | Cross Contamination With Other Products: | Boehringer Ingelheim Pharmaceuticals, Inc. / 998 180-count bottles | Class II | Terminated |
| D-1191-2018 | 09-04-2018 | Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153 Package NDCs: 55111-179-30; 55111-179-15; 55111-179-03; 55111-179-10; 55111-180-30; 55111-180-15; 55111-180-03; 55111-180-10; 3551117915 | Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets . | Dr. Reddy's Laboratories, Inc. / 8376 units | Class II | Terminated |
| D-1192-2018 | 08-31-2018 | Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7002-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 192 bottles | Class II | Terminated |
| D-1199-2018 | 08-31-2018 | Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7042-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 140 bottles | Class II | Terminated |
| D-1197-2018 | 08-31-2018 | Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7011-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 124 bottles | Class II | Terminated |
| D-1193-2018 | 08-31-2018 | Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7013-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 90 bottles | Class II | Terminated |
| D-1196-2018 | 08-31-2018 | Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7041-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 109 bottles | Class II | Terminated |
| D-1198-2018 | 08-31-2018 | Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7012-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 314 bottles | Class II | Terminated |
| D-1194-2018 | 08-31-2018 | Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7014-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 420 bottles | Class II | Terminated |
| D-0002-2019 | 08-31-2018 | NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02 Package NDCs: 58368-002-02 | CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product. | BioLyte Laboratories, LLC / a) 500 sample packs; b) 672 bottles | Class II | Terminated |
| D-1195-2018 | 08-31-2018 | Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7022-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 160 bottles | Class II | Terminated |
| D-0008-2019 | 08-30-2018 | Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298, NDC 7807-0170-11 | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Alkano Chemicals, Inc / 8 kgs | Class II | Terminated |
