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-364-2013 | 04-10-2013 | Estradiol Cypionate Injection, all strengths and all presentations including a) Estradiol Cypionate 5 mg/mL 10 mL and b) Estradiol Cypionate 10 mg/mL 10 ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 48 vials | Class II | Terminated |
| D-385-2013 | 04-10-2013 | Manganese Sulfate Injection, all strengths and all presentations including a) Manganese-0.1 30 mL, b) Manganese Sulfate 0.1 mg/30 mL, c) Manganese Sulfate 5 mg/5 mg, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 133 vials | Class II | Terminated |
| D-375-2013 | 04-10-2013 | Hydroxyprogesterone Caproate Injection, all strengths and all presentations including Hydroxyprogesterone Caproate 250 mg/mL 1 mL, 4 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 229 vials | Class II | Terminated |
| D-383-2013 | 04-10-2013 | Magnesium Chloride Injection, all strengths and all presentations including a) Magnesium Chloride 200 mg/50 mL and b) Magnesium Chloride 200 mg/mL 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 197 vials | Class II | Terminated |
| D-409-2013 | 04-10-2013 | Sodium Tetradecyl Sulfate Injection, all strengths and all presentations including a) Sodium Tetradecyl Sulfate 3% 50 mL, b) Sodium Tetradecyl Sulfate 3% mL, c) Sodium Tetradecyl Sulfate-2% 30 mL, d) Sodium Tetradecyl Sulfate-2.5% 20 mL, e) Sodium Tetradecyl Sulfate 0.3% 30 mL, f) Sodium Tetradecyl Sulfate 1% 30 mL, 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 203 vials | Class II | Terminated |
| D-356-2013 | 04-10-2013 | Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% Aqueous Solution 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 1 vial | Class II | Terminated |
| D-359-2013 | 04-10-2013 | Dimercapto-propane-sulfonic acid (DMPS) Injection, all strengths and all presentations including a) DMPS 50 mg/5 mL, b) DMPS 50 mg/mL PF 5 mL, c) DMPS Acid 250 mg/5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 251 vials | Class II | Terminated |
| D-371-2013 | 04-10-2013 | Hyaluronidase Injection, all strengths and all presentations including a) Hyaluronidase 150u/mL, b) Hyaluronidase 150u/ml 1 mL PF, c) Hyaluronidase 150u/mL PF 1ml SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 996 vials | Class II | Terminated |
| D-365-2013 | 04-10-2013 | Estradiol Valerate Injection, all strengths and all presentations including a) Estradiol Valerate 40-10 mL and b) Estradiol Valerate 40-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 243 vials | Class II | Terminated |
| D-397-2013 | 04-10-2013 | Nandrolone Decanoate Injection, all strengths and all presentations including a) Nandrolone Decanoate 300 mg/mL, b) Nandrolone 200 mg/mL, c) Nandrolone 250 mg/mL, d) Nandrolone 350 mg/mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 43 vials | Class II | Terminated |
| D-343-2013 | 04-10-2013 | Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 4368 vials | Class II | Terminated |
| D-414-2013 | 04-10-2013 | Thiamine Hydrochloride Injection, all strengths and all presentations including a) Thiamine 100 mg/30 mL, b) Thiamine Hydrochloride 100 mg/mL with preservative 30 mL, c) Thiamine Hydrochloride 50 mg/mL with preservative 30 mL, d) Thiamine Hydrochloride 100 mg/mL preservative free 10 mL and 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 70 vials | Class II | Terminated |
| D-351-2013 | 04-10-2013 | Bupivacaine and Dexamethasone Injection, all strengths and all presentations including Bupiv_Dexameth-0.25-10.5; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 1150 vials | Class II | Terminated |
| D-393-2013 | 04-10-2013 | Methylprednisolone Acetate Injection, all strengths and all presentations including a) Methylprednisolone Acetate 40 mg/mL, b) Methylprednisolone Acetate (PF) 40 mg/mL, c) Methylprednisolone Acetate (PF) 80 mg/mL, d) Methylpred Acetate 40 mg/mL 1 mL, e) Methylprednisolone 80 mg/5 mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 4350 vials and syringes | Class II | Terminated |
| D-367-2013 | 04-10-2013 | Furosemide Injection, all strengths and all presentations including a) Furosemide PF-10 mg-10 mL, b) Furosemide PF-10 mg-2 mL SDV, and Furosemide 10 mg/mL 4 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 227 vials | Class II | Terminated |
| D-341-2013 | 04-10-2013 | Amikacin Injection, all strengths and all presentations including 50, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / unknown | Class II | Terminated |
| D-347-2013 | 04-10-2013 | BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 435 vials and syringes | Class II | Terminated |
| D-378-2013 | 04-10-2013 | L-Glutathione Injection, all strengths and all presentations including a) L-Glut-100 mg-30 mL, b) L-Glut-200 mg/30 mL, c) Glutathione 200 mg/ML P.F. 10 mL, d) L-Glutathione-200-30 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 430 vials | Class II | Terminated |
| D-408-2013 | 04-10-2013 | Sodium Chloride Injection, all strengths and all presentations including a) Bacteriostatic Sodium Chloride 0.9% 30 mL, b) Sodium Chloride 23.4% 30 mL PF, and c) Sodium Chloride 23.4% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 318 vials | Class II | Terminated |
| D-412-2013 | 04-10-2013 | Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection, all strengths and all presentations including Test Prop 100 mg/Test Cyp 50 mg/nandro dec 150 mg/ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 2 vials | Class II | Terminated |
| D-376-2013 | 04-10-2013 | Ketorolac Injection, all strengths and all presentations including a) Ketorolac 30 mg/mL 10 mL MDV, b) Ketorolac 30 mg/mL 2 mL SDV, c) Ketorolac 30 mg/mL 1 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 3289 vials | Class II | Terminated |
| D-401-2013 | 04-10-2013 | Procaine Hydrochloride Injection, all strengths and all presentations, including a) Procaine 2% 30 mL PF, b) Procaine HCl 2% 10 mL, c) Procaine HCl 20 mg/mL 30 mL, d) Procaine HCl 1% 50 mL MDV, e) Procaine HCl 1% PF 5 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 70 vials | Class II | Terminated |
| D-369-2013 | 04-10-2013 | Glycerin/Lidocaine/Epinephrine Injection including Glycerin 72% Lido:Epi 2-1-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / unknown | Class II | Terminated |
| D-390-2013 | 04-10-2013 | Methylprednisolone and Bupivacaine Injection, all strengths and all presentations including Methylpred80mg/bupivacaine0.25% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 52 syringes | Class II | Terminated |
| D-346-2013 | 04-10-2013 | Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3 mL, b) Betameth_Combo_PF-6-2 Syr, and c) Betamethasone Combo 6 mg/mL Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 295 vials and syringes | Class II | Terminated |
| D-406-2013 | 04-10-2013 | Nandrolone Decanoate and Testosterone Cypionate Injection, all strengths and all presentations including a) Nandrolone 100 mg/mL TestCyp 100 mg/mL 10 mL and b) Nandrolone 100 mg/mL TestCyp 200 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 5 vials | Class II | Terminated |
| D-362-2013 | 04-10-2013 | Edetate Calcium Disodium Injection, all strengths and all presentations including a) Edetate Calcium Disodium 300 mg/mL 100 mL, b) Edetate Calcium Disodium 300-30 mL, c) Calcium Edetate 200 mg/mL 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 227 vials | Class II | Terminated |
| D-374-2013 | 04-10-2013 | Hydroxocobalamin Injection, all strengths and all presentations including a) Hydroxocobalamin 1000 mcg/mL 30mL and b) Hydroxocobalamin 1000 mcg/mL 10 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 135 vials | Class II | Terminated |
| D-386-2013 | 04-10-2013 | Medroxyprogesterone Acetate Injection, all strengths and all presentations including a) Medroxyprogesterone 150-30 mL, b) Medroxyprogesterone Acetate 150 mg/mL in 1 mL, 10 mL, 30 mL vials, c) Medroxyprogesterone Acetate 150 mg/mL PF syringe, d) Medroxyprogesterone Acetate 150 mg/mL syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 1299 vials and syringes | Class II | Terminated |
| D-344-2013 | 04-10-2013 | Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 597 vials | Class II | Terminated |
| D-394-2013 | 04-10-2013 | Metoprolol Injection, all strengths and all presentations including Metoprolol 1 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 65 vials | Class II | Terminated |
| D-366-2013 | 04-10-2013 | Folic Acid Injection, all strengths and all presentations including a) Folic Acid 10 mg/mL 30 mL; b) Folic Acid PF 10 mg/mL 2 mL and 5 mL; c) Folic Acid 20 mg/mL 30 mL; d) Folic Acid 5 mg/mL 5 mL, 10 ml and 30 mL Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 244 vials | Class II | Terminated |
| D-402-2013 | 04-10-2013 | Progesterone Injection, all strengths and all presentations including a) Progesterone 100 mg/mL 10 mL, 30 mL b) Progesterone 50 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 13 vials | Class II | Terminated |
| D-339-2013 | 04-10-2013 | Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 93 vials | Class II | Terminated |
| D-415-2013 | 04-10-2013 | Triamcinolone Injection, all strengths and all presentations including a) Triamcinolone 40 mg/1 mL PF, b) Triamcinolone Acetonide 45 mg/mL, c) Triamcinolone 50 mg/mL 5 mL PF, d) Triamcinolone 45 mg/mL10 mL, 30 mL, e) Triamcinolone 40 mg/mL SDV PF 1 mL, 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 1423 vials | Class II | Terminated |
| D-405-2013 | 04-10-2013 | Sodium Bicarbonate and Lidocaine Injection, all strengths and all presentations including Sod-Bicarb-Lido-0.27-2.73-3 syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 335 vials | Class II | Terminated |
| D-363-2013 | 04-10-2013 | ED Mix Injections, all strengths and all presentations including a) ED mix TM -at 2, b) ED-Mix BI-Mix 10 30 mL, c) ED-Mix BI-Mix 9 30 mL; d) ED-Mix BI-Mix-3-30, e) ED-Mix PGE 80-30, f) ED-Mix SB4 30 mL, g) Ed-Mix ST 9E, h) ED-Mix ST-1, i) ED-MIX T106, j) ED-MIX-PGE-150 30 mL, k) ED-MIX-PGE-40-30, l) ED-MIX-ST 9A, m) ED-MIX-ST 9D, n) ED-MIX-ST-9B, o) ED-MIX-T 101, p) ED-MIX-T105, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 10684 vials | Class II | Terminated |
| D-392-2013 | 04-10-2013 | Lipotropic With Vitamins, Carnitine, Chromium and Glutamine Injection, all strengths and all presentations including Lipo W/Vitamin-Carn-Crom_Glut-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 19 vials | Class II | Terminated |
| D-404-2013 | 04-10-2013 | Sodium Chloride and Dexamethasone Injection, all strengths and all presentations including a) SOD_CHLOR-DEXAMETH-0.9-10-3, b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 950 syringes | Class II | Terminated |
| D-358-2013 | 04-10-2013 | Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250 mg/30 mL; Dexpanthenol 250 mg/mL 10 mL, 30 mL, 50 mL; and Dexpanthenol 250 mg/mL 10 mL P.F.; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 273 vials | Class II | Terminated |
| D-389-2013 | 04-10-2013 | Methylprednisolone and Dexamethasone Injection, all strengths and all presentations including a) Methylpred/ Dexameth 1-2-3 mL and b) Methylpred/Dexa 3 mL PFS; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 430 vials and syringes | Class II | Terminated |
| D-384-2013 | 04-10-2013 | Magnesium Sulfate Injection, all strengths and all presentations including a) Magnesium Sulfate 50%; b) MAGNESIUM SULFATE 50% 50 mL, c) Magnesium Sulfate PF 50% 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 529 vials | Class II | Terminated |
| D-407-2013 | 04-10-2013 | Sodium Bicarbonate Injection, all strengths and all presentations including: a) Sodium Bicarb 4.2% 5 mL PF, b) Sodium Bicarb 8.4% 50 mL SDV, c) Sodium Bicarbonate 8.4%, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 6213 vials | Class II | Terminated |
| D-889-2013 | 04-09-2013 | 3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789 | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride. | Total Resources Intl / | Class II | Terminated |
| D-890-2013 | 04-09-2013 | Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Travel, Sport, Total Resources International, Walnut, CA 91789 | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride. | Total Resources Intl / | Class II | Terminated |
| D-891-2013 | 04-09-2013 | (No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET PREPARED,326 Pieces of Name Brand & Quality First Aid Supplies, FIRST AID, Total Resources International, Walnut, CA 91789 | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride. | Total Resources Intl / | Class II | Terminated |
| D-498-2013 | 04-09-2013 | Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India Package NDCs: 65862-037-30; 65862-037-01; 65862-037-00; 65862-037-05; 65862-037-99; 65862-038-30; 65862-038-01; 65862-038-00; 65862-038-05; 65862-038-99; 65862-039-30; 65862-039-01; 65862-039-00; 65862-039-05; 65862-039-99; 65862-040-30; 65862-040-01; 65862-040-00; 65862-040-05; 65862-040-99; 65862-041-30; 65862-041-01; 65862-041-00; 65862-041-05; 65862-041-99; 65862-042-30; 65862-042-01; 65862-042-00; 65862-042-05; 65862-042-99 | Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label | Aurobindo Pharma USA Inc / 1776 bottles | Class III | Terminated |
| D-418-2013 | 04-08-2013 | BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO 00717-1565 -- NDC 58552-103-01 | Subpotent; Cetylpyridinum Chloride | Hi-Tech Pharmacal Co., Inc. / 10,440 bottles | Class III | Terminated |
| D-297-2013 | 04-08-2013 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25; 0409-1511-97; 0409-1511-98; 0409-0501-97; 0409-0501-98; 0409-0010-97; 0409-0010-98 | Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection. | Hospira Inc. / 245,250 vials | Class II | Terminated |
| D-331-2013 | 04-05-2013 | Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430 Package NDCs: 68462-108-60; 68462-108-05; 68462-108-10; 68462-153-60; 68462-153-05; 68462-153-10; 68462-109-60; 68462-109-05; 68462-109-10; 68462-110-60; 68462-110-05; 68462-110-10 | Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature. | Glenmark Generics Inc., USA / 9624 bottles | Class III | Terminated |
| D-329-2013 | 04-05-2013 | Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430. Package NDCs: 68462-126-01; 68462-126-05; 68462-127-01; 68462-127-05 | Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature. | Glenmark Generics Inc., USA / a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct) | Class III | Terminated |
| D-330-2013 | 04-05-2013 | Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430 Package NDCs: 68462-195-90; 68462-195-05; 68462-196-90; 68462-196-05; 68462-197-90; 68462-197-05; 68462-198-90; 68462-198-05 | Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature. | Glenmark Generics Inc., USA / 246,528 bottles | Class III | Terminated |
| D-419-2013 | 04-04-2013 | Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8. | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. | Aaron Industries Inc / 27,144 bottles | Class III | Terminated |
| D-002-2014 | 04-03-2013 | Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59 | Resuspension Problems: Recalled lot did not meet resuspendability requirements. | Boehringer Ingelheim Roxane Inc / 10,267 bottles | Class II | Terminated |
| D-019-2014 | 04-02-2013 | Cetacaine Liquid Topical Anesthetic, Rx Only, a) 14 g bottle (NDC 10223-0202-2); Kit w/14 g (NDC 10223-0202-3); 30 g bottle (NDC 10223-0202-4) Manufactured by Cetylite Industries, Inc., 9051 River Road Pennsauken, NJ 08110 - Package NDCs: 10223-0202-2; 10223-0202-4; 10223-0202-5; 10223-0202-6; 10223-0202-7; 10223-0202-8; 10223-0225-1; 10223-0226-1; 10223-0202-3 | Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients, tetracaine, is below the specification limit at the 21 month stability test point. | Cetylite Industries, Inc. / 30 g - 11403 units; 14 g - 7338 units 14 g kit - 200 units | Class II | Terminated |
| D-437-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 5,767,711 tablets | Class II | Terminated |
| D-438-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.100 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 21,019,909 tablets | Class II | Terminated |
| D-448-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 137 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1331-01. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 12,911 Bottles | Class II | Terminated |
| D-451-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 200 mcg, RX only, 100 tablets per bottle. Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1327-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 29,489 Bottles | Class II | Terminated |
| D-450-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1326-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 32,345 Bottles | Class II | Terminated |
| D-443-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.175 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 5,768,782 tablets | Class II | Terminated |
| D-444-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 5,771,989 tablets | Class II | Terminated |
| D-449-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 150 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1325-01. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 61,347 Bottles | Class II | Terminated |
| D-441-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 3,844,402 tablets | Class II | Terminated |
| D-440-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 13,460,920 tablets | Class II | Terminated |
| D-446-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 112 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1330-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 40,311 Bottles | Class II | Terminated |
| D-445-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 100 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1323-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 142,103 Bottles | Class II | Terminated |
| D-432-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1321-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 4,440 Bottles | Class II | Terminated |
| D-439-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 7,614,709 tablets | Class II | Terminated |
| D-434-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1322-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 19,787 Bottles | Class II | Terminated |
| D-436-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 88 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1329-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 12,156 Bottles | Class II | Terminated |
| D-447-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP) , 125 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1324-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 77,471 Bottles | Class II | Terminated |
| D-435-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 9,545,718 tablets | Class II | Terminated |
| D-442-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.150 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 9,575,108 tablets | Class II | Terminated |
| D-433-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 7,681,277 tablets | Class II | Terminated |
| D-325-2013 | 04-01-2013 | ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts. | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug. | Consumer Concepts, Inc. / 11,424 blister packs | Class I | Terminated |
| D-836-2013 | 03-29-2013 | 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09. | Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates | Hospira Inc. / 691,356 containers | Class I | Terminated |
| D-417-2013 | 03-28-2013 | Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244 | Lack of Assurance of Sterility; reports of adverse events after injection | NuVision Pharmacy, Inc. / 32 vials | Class II | Terminated |
| D-261-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. 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 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 14464 bottles | Class II | Completed |
| D-257-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. 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 | Chemical contamination: emission of strong odor after package was opened | Pfizer Inc. / 37891 bottles | Class II | Completed |
| D-256-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. 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 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 9213 bottles | Class II | Completed |
| D-258-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. 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 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 7901 bottles | Class II | Completed |
| D-254-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. 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 | Chemical contamination: emission of strong odor after package was opened.. | Pfizer Inc. / 26447 bottles | Class II | Completed |
| D-252-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 60793-851-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. 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 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 29613 bottles | Class II | Completed |
| D-260-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. 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 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 10121 bottles | Class II | Completed |
| D-255-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. 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 | Chemical contamination: emission of strong odor after package was opened.. | Pfizer Inc. / 18195 bottles | Class II | Completed |
| D-251-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. 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 | Chemical contamination: emission of strong odor after package was opened.. | Pfizer Inc. / 23210 bottles | Class II | Completed |
| D-259-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. 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 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 36045 bottles | Class II | Completed |
| D-253-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. 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 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 37809 bottles | Class II | Completed |
| D-580-2013 | 03-27-2013 | Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60 | Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009 | Legacy Pharmaceutical Packaging LLC / 1,644 bottles | Class III | Terminated |
| D-866-2013 | 03-25-2013 | Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-865-2013 | 03-25-2013 | Diazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 7 vials | Class II | Terminated |
| D-877-2013 | 03-25-2013 | Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 10 vials | Class II | Terminated |
| D-861-2013 | 03-25-2013 | BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 246 vials | Class II | Terminated |
| D-873-2013 | 03-25-2013 | Nandrolone Decanoate Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 56 vials | Class II | Terminated |
| D-874-2013 | 03-25-2013 | Quadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 2 vials | Class II | Terminated |
| D-868-2013 | 03-25-2013 | Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-864-2013 | 03-25-2013 | Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-875-2013 | 03-25-2013 | Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-870-2013 | 03-25-2013 | Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
