| Dec 17, 2018 |
Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding ... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Ph... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, ... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promi... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialis... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide De... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy C... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, ... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialis... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pha... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compo... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Com... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise P... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Ph... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compou... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compound... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy C... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialist... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Pro... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compoun... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compound... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%,... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialist... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcob... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding ... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compoundin... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.0... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy C... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thi... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Speci... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compo... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compound... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Com... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Dec 17, 2018 |
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy... |
Lack of sterility assurance. |
Class II |
Promise Pharmacy, LLC |
| Nov 30, 2018 |
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged... |
Failed Impurities/Degradation Specifications:Out of specification for impurities. |
Class III |
VistaPharm, Inc. |
| Nov 6, 2018 |
Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Di... |
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribu... |
Class III |
Breckenridge Pharmaceutical, Inc. |
| Oct 18, 2018 |
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bott... |
Presence of precipitate |
Class III |
Promise Pharmacy LLC |
| Oct 15, 2018 |
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sa... |
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine |
Class II |
Zero Xtreme USA |