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Drug recalls

Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II November 7, 2018 Epi-Shugarcaine Kit Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1409-60 Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Prostaglandin E1 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Methylcobalamin 1 mg/mL a) 10 mL Injectable NDC 69699-1501-10; b) 30 mL Injectable NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 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 Terminated
Class II November 7, 2018 HCG 10,000 unit/0.3 gm Mannitol Lyopholized, Pharm D Solutions, Houston, Texas ---- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65 mg/Phentolamine 0.59 mcg… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO)… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20 Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Slenderella Compound Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-30 Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 69699-1610-30 Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Oxytocin 30 unit in LR 500 mL 0.06 units/mL IV,Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a… Lack of assurance of sterility Avella of Deer Valley, Inc. Store 38 Terminated
Class II November 7, 2018 Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm D… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix AT-6 Papa 30 mg/Phent 4 mg/Atrop. 0.3 mg Injectable, Pharm D Solutions, Houston,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas ---- NDC 69699-1439-59 Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Phenol 5% and Glycerin Aqueous Solution 10 mL Injection, Pharm D Solutions, Houston,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texas ---- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10 Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per mL… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution Compound… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Irbesartan Bulk Active Pharmaceutical Ingredient. CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. Aurobindo Pharma Limited (Unit I) Terminated
Class II November 7, 2018 Sermorelin/GHRP-2/Theanine/Mannitol 15 mg/6 mg/75 mg/300 mg Powder, Pharm D Solutions,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, Houston,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions, Houston, Texas ---- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella… Lack of assurance of sterility Avella of Deer Valley, Inc. Store 38 Terminated
Class II November 7, 2018 Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 HCG Reconstitued 6000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Testosterone in Grapeseed Oil 200 mg/mL, a) 4 mL, b) 5 mL, c) 10 mL and d) 30 mL… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, Houston,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Sermorelin/GHRP-2 9 mg-6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous Solution,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable, Pharm D… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Reck Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1459-50 Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Tilarginine Acetate 50 mg/mL, 10 mL, Injectable, Pharm D Solutions, Houston, Texas ---… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 HCG 6000 unit/0.3 gm Mannitol Lyopholized 6000 IU/vial injectable, Pharm D Solutions,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class III November 7, 2018 Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Sermorelin/GHRP-2/GHRP-6 Mannitol 9 mg/9 mg/9 mg/300 mg Powder, Pharm D Solutions,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 HCG 50,000 unit/0.3 gm Mannitol Lyophilized Powder Pharm D Solutions, Houston, Texas ---… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Glycerin 72% (Lidocaine/Epi 2:1) Injectable, Pharm D Solutions, Houston, Texas ---- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable, Pharm D Solutions, Houston,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D Solutions,… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Bacteriostatic Water for Injection 10 mL, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II November 7, 2018 Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Prostaglandin E1 80 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 0.9% Sodium Chloride for Injection, 50 mL bags, Pharm D Solutions, Houston, Texas --- NDC… Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05 Lack of Assurance of Sterility Pharm D Solutions, LLC Terminated
Class II November 7, 2018 Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Sprayology Terminated
Class II October 31, 2018 Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC… Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect… Teva Pharmaceuticals USA Terminated
Class II October 31, 2018 Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By… Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle Heritage Pharmaceuticals, Inc. Terminated
Class II October 31, 2018 Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340… Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent. RXQ Compounding LLC Terminated
Class II October 31, 2018 ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide… Lack of Process Controls Westlab Pharmacy, Inc. dba Westlab Pharmacy Terminated
Class II October 31, 2018 Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard… CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical… RemedyRepack Inc. Terminated
Class II October 31, 2018 Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only,… Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect… Teva Pharmaceuticals USA Terminated
Class III October 31, 2018 Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only,… Presence of precipitate Promise Pharmacy LLC Terminated
Class II October 31, 2018 Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only,… Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability… Teva Pharmaceuticals USA Terminated
Class II October 31, 2018 Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607… Incorrect Product Formulation Westlab Pharmacy, Inc. dba Westlab Pharmacy Terminated
Class II October 31, 2018 Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only,… Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect… Teva Pharmaceuticals USA Terminated
Class II October 31, 2018 Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only,… Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect… Teva Pharmaceuticals USA Terminated
Class II October 31, 2018 fluocinolone acetonide Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin… Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during… LUPIN SOMERSET Terminated
Class II October 31, 2018 Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed… CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due… Valeant Pharmaceuticals North America LLC Terminated
Class II October 31, 2018 Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only,… Lack of assurance of sterility: loss of container integrity. Pfizer Inc. Terminated
Class II October 31, 2018 Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray… CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due… Valeant Pharmaceuticals North America LLC Terminated
Class II October 31, 2018 Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC… Lack of Process Controls Westlab Pharmacy, Inc. dba Westlab Pharmacy Terminated
Class II October 31, 2018 PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand… Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect… Teva Pharmaceuticals USA Terminated
Class II October 31, 2018 Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube,… CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due… Valeant Pharmaceuticals North America LLC Terminated
Class II October 31, 2018 Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC… Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect… Teva Pharmaceuticals USA Terminated
Class II October 31, 2018 Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only,… Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect… Teva Pharmaceuticals USA Terminated
Class II October 31, 2018 Hydroxyzine Hydrochloride HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per… CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities. Lannett Company, Inc. Terminated
Class II October 31, 2018 Bumetanide Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith… Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product. Upsher Smith Laboratories, Inc. Terminated
Class III October 31, 2018 Testosterone Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for:… Defective Container: Repetitive complaints received indicating pump not working. Lupin Pharmaceuticals Inc. Terminated
Class II October 31, 2018 Bumetanide Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith… Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product. Upsher Smith Laboratories, Inc. Terminated
Class II October 24, 2018 Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) 1.5 FL OZ… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class III October 24, 2018 Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b)… Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing. Amerigen Pharmaceuticals Inc. Terminated
Class II October 24, 2018 Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain… CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active… Humco Holding Group, Inc Terminated
Class II October 24, 2018 Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (120 g) can,… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Distributed… Superpotent Drug: high out of specification assay results for the camphor ingredient. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva… Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability… Teva Pharmaceuticals USA Terminated
Class II October 24, 2018 Best Choice, 12 Hour No-Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class I October 24, 2018 Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle,… Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%,… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B… Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net… Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562. CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class III October 24, 2018 Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone… Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube,… Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding… Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant,… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery Elm, 3 FL… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy, Inc. One… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class III October 24, 2018 Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone… Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%,… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ (30 mL)… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, packaged as a)… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL)… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active… CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active… Humco Holding Group, Inc Terminated
Class II October 24, 2018 Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube, Distributed… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochloride 0.05%),… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml),… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by:… Failed Stability Specifications: separation of product and failure for actives. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Rite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazoline… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL)… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By:… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113… Superpotent Drug: high out of specification assay results for the menthol ingredient. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Premier Value, Nasal Decongestant, No Drip Nasal Spray (oxymetazoline HCl) Nasal… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%,… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active… CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active… Humco Holding Group, Inc Terminated
Class II October 24, 2018 meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL)… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate… Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9;… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, Distributed… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Best Choice, 12 Hour Sinus Relief, Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube,… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Walgreens, NO DRIP Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant,… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400… Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ (30… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class II October 24, 2018 Premier Value, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride)… CGMP Deviations: products manufactured under conditions that could impact its product quality. Product Quest Manufacturing LLC Terminated
Class III October 24, 2018 Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3… Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs. Mylan Pharmaceuticals Inc. Terminated
Class II October 17, 2018 Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, Thyroid… CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active… Alkano Chemicals, Inc Terminated
Class II October 17, 2018 Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a… CGMP deviations GLAXOSMITHKLINE NEBRASKA Terminated
Class II October 17, 2018 Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000… Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core… Takeda Development Center Americas, Inc. Terminated
Class III October 17, 2018 ALTAVERA Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only,… Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause… Xiromed LLC Terminated
Class II October 17, 2018 THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain;… CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active… Syntec Pharma Corp Terminated
Class II October 17, 2018 THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine… CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active… Syntec Pharma Corp Terminated
Class II October 17, 2018 Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only… CGMP Deviations; rejected product was used to manufacture final bulk lot Pfizer Inc. Terminated
Class II October 17, 2018 Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only,… Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets. Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class III October 17, 2018 Amlodipine Besylate Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by:… Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term… InvaGen Pharmaceuticals, Inc. Terminated
Class II October 17, 2018 Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL… Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium… Pfizer Inc. Terminated
Class I October 10, 2018 robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed… Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four… Endo Pharmaceuticals, Inc. Terminated
Class III October 10, 2018 treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended… Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is… Otsuka Pharmaceutical Development & Commercialization, Inc. Terminated
Class III October 10, 2018 treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended… Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is… Otsuka Pharmaceutical Development & Commercialization, Inc. Terminated
Class II October 10, 2018 Clozapine Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva… Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability… Teva Pharmaceuticals USA Terminated
Class II October 10, 2018 Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD,… CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. Sichuan Friendly Pharmaceutical Co.,Ltd. Terminated
Class II October 10, 2018 Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in… Failed stability specifications - An out of specification result was observed for the test parameter : composition of… Dr. Reddy's Laboratories, Inc. Terminated
Class II October 10, 2018 Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only,… Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either… Pfizer Inc. Terminated
Class II October 10, 2018 NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml… CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to… BioLyte Laboratories, LLC Terminated
Class III October 3, 2018 Zoledronic Acid Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx… Failed Impurities/Degradation Specifications: OOS for unknown impurities. Dr. Reddy's Laboratories, Inc. Terminated
Class II October 3, 2018 Montelukast Sodium Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs… Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets. Hetero Labs Limited Unit V Terminated
Class III October 3, 2018 Fenofibrate Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber… Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle… Hetero Labs, Ltd. - Unit III Terminated
Class I October 3, 2018 Montelukast Sodium Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs… Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan… Hetero Labs Limited Unit V Ongoing
Class III October 3, 2018 Levofloxacin Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24),… Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. Baxter Healthcare Corporation Terminated
Class II October 3, 2018 Minivelle Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8… Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of… Noven Pharmaceuticals, Inc. Terminated
Class II October 3, 2018 Minivelle Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes,… Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of… Noven Pharmaceuticals, Inc. Terminated
Class III October 3, 2018 Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland… Failed Impurities/Degradation Specifications: OOS for unknown impurities. Dr. Reddy's Laboratories, Inc. Terminated
Class II October 3, 2018 Minivelle Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8… Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of… Noven Pharmaceuticals, Inc. Terminated
Class II October 3, 2018 Minivelle Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes,… Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of… Noven Pharmaceuticals, Inc. Terminated
Class II October 3, 2018 Synjardy Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only.… Cross Contamination With Other Products: Boehringer Ingelheim Pharmaceuticals, Inc. Terminated
Class II September 26, 2018 Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Beaumont Bio-med, Inc. Terminated
Class II September 26, 2018 Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Beaumont Bio-med, Inc. Terminated
Class II September 26, 2018 Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Beaumont Bio-med, Inc. Terminated
Class II September 26, 2018 Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Beaumont Bio-med, Inc. Terminated
Class II September 26, 2018 Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Beaumont Bio-med, Inc. Terminated
Class I September 26, 2018 Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx… Subpotent Drug: Product may not have the active ingredient present in the bag. QuVa Pharma, Inc. Terminated
Class II September 26, 2018 Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Beaumont Bio-med, Inc. Terminated
Class III September 26, 2018 bupropion hydrochloride Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC… Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic… InvaGen Pharmaceuticals, Inc. Terminated
Class II September 26, 2018 Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Beaumont Bio-med, Inc. Terminated
Class II September 26, 2018 Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass… CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible… Beaumont Bio-med, Inc. Terminated
Class III September 26, 2018 MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista… Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for… Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class II September 26, 2018 Lamotrigine Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only,… Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point… Torrent Pharma Inc. Terminated
Class II September 26, 2018 SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation… cGMP Deviation Baxter Healthcare Corporation Terminated
Class III September 26, 2018 Morphine Sulfate Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured… Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out… LUPIN SOMERSET Terminated
Class II September 26, 2018 Tizanidine Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's… Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets . Dr. Reddy's Laboratories, Inc. Terminated
Class I September 19, 2018 Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife,… Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to… Hellolife Terminated
Class III September 19, 2018 Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan… Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability… Mylan Pharmaceuticals Inc. Terminated
Class III September 19, 2018 Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count… Failed impurities/degradation specifications: Finished product contain a known product impurity about current… Par Pharmaceutical, Inc. Terminated
Class I September 19, 2018 Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife,… Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to… Hellolife Terminated
Class I September 19, 2018 Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife,… Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to… Hellolife Terminated
Class I September 19, 2018 Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife,… Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to… Hellolife Terminated
Class III September 19, 2018 Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan… Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability… Mylan Pharmaceuticals Inc. Terminated
Class I September 19, 2018 Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose… Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient… SCA Pharmaceuticals, Inc. Terminated
Class III September 19, 2018 Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only,… Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point Pfizer Inc. Terminated
Class III September 19, 2018 Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation… Defective Delivery System: Water ingress through the lower water cup sensor of the device. United Therapeutics Corp. Terminated
Class I September 19, 2018 Hydrochlorothiazide Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for:… Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained… Accord Healthcare, Inc. Terminated
Class II September 12, 2018 AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Avkare Incorporated Terminated
Class II September 12, 2018 AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Avkare Incorporated Terminated
Class II September 12, 2018 AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Avkare Incorporated Terminated
Class II September 12, 2018 AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Avkare Incorporated Terminated
Class II September 12, 2018 AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Avkare Incorporated Terminated
Class II September 12, 2018 Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm… Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity. Akorn, Inc. Terminated
Class II September 12, 2018 Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20… Supterpotent Drug Mckesson Corporation Terminated
Class II September 5, 2018 Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs… Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be… Auro Pharmacies, Inc. Terminated
Class II September 5, 2018 Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs… Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be… Auro Pharmacies, Inc. Terminated
Class II September 5, 2018 Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs… Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be… Auro Pharmacies, Inc. Terminated
Class II September 5, 2018 Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Torrent Pharma Inc. Ongoing
Class II September 5, 2018 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Torrent Pharma Inc. Ongoing
Class II September 5, 2018 Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs… Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be… Auro Pharmacies, Inc. Terminated
Class II September 5, 2018 Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5… Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be… Auro Pharmacies, Inc. Terminated
Class II September 5, 2018 Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard… CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical… RemedyRepack Inc. Terminated
Class II September 5, 2018 Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Torrent Pharma Inc. Ongoing
Class II September 5, 2018 Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL… Lack of assurance of sterility. Pharmcore Inc. Terminated
Class II September 5, 2018 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Torrent Pharma Inc. Ongoing
Class II September 5, 2018 Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs… Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be… Auro Pharmacies, Inc. Terminated
Class II September 5, 2018 Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. AVKARE Inc. Terminated
Class II September 5, 2018 Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. AVKARE Inc. Terminated
Class II September 5, 2018 Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd.… Lack of assurance of sterility. Pharmcore Inc. Terminated
Class II September 5, 2018 Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL… Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be… Auro Pharmacies, Inc. Terminated
Class II September 5, 2018 Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5… Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be… Auro Pharmacies, Inc. Terminated
Class II September 5, 2018 Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Torrent Pharma Inc. Ongoing
Class II September 5, 2018 Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd.… Lack of assurance of sterility. Pharmcore Inc. Terminated
Class II September 5, 2018 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Torrent Pharma Inc. Ongoing
Class II September 5, 2018 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Torrent Pharma Inc. Ongoing
Class II September 5, 2018 Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose… Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be… Auro Pharmacies, Inc. Terminated
Class II September 5, 2018 Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. AVKARE Inc. Terminated
Class II September 5, 2018 Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Torrent Pharma Inc. Ongoing
Class II September 5, 2018 Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Torrent Pharma Inc. Ongoing
Class II September 5, 2018 Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd.… Lack of assurance of sterility. Pharmcore Inc. Terminated
Class II September 5, 2018 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Torrent Pharma Inc. Ongoing
Class II September 5, 2018 Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd.… Lack of assurance of sterility. Pharmcore Inc. Terminated
Class III September 5, 2018 Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only,… Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot… Mayne Pharma Inc Terminated
Class II September 5, 2018 Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach,… Lack of assurance of sterility. Pharmcore Inc. Terminated
Class II September 5, 2018 CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs… Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be… Auro Pharmacies, Inc. Terminated
Class II September 5, 2018 Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Torrent Pharma Inc. Ongoing
Class II September 5, 2018 Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs… Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be… Auro Pharmacies, Inc. Terminated