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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 January 11, 2017 Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Sermorelin Acetate/GHRP (2) & (6) 9 mg/9 mg/9 mg Injectable Kit, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Sermorelin Acetate/GHRP (6) 3 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells Pharmacy,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc.,… CGMP Deviations Apotex Corp. Terminated
Class II January 11, 2017 TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL, (1 ML). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Sermorelin Acetate 28 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL Injectable, 30 mL vial, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Sermorelin Acetate 15 mg Injectable Kit., Compounded by Wells Pharmacy, Ocala, FL Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class III January 11, 2017 TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST… Failed Stability Specifications Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals Terminated
Class II January 11, 2017 Trimix Injectable 30 mg/3 mg/100 mcg/mL, a) 5 mL and 10 mL vials, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Indocyanine Green (P.F.), 15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Testosterone Cypionate in Sesame Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg +… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/mL, (1 ML). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Testosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/mL… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Glutamine/ORNI/ARGIN/LYSINE/LIDO Injectable, 75 mg/75 mg/150 mg/150 mg/10 mg/mL, 30 mL… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocaine HCL 10… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Glucosamine 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Trimix Injectable 30 mg/1 mg/25 mcg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 MIC/B12/CAR/CHR/LYS/DMG 25 mg/50 mg/50 mg/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL Injectable,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Testosterone Cypionate/Propionate, 200 mg/50 mg/mL, (5 ML). Compounded by Tri-Coast… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Testosterone Propionate Injectable, 100 mg/mL, 10 mL vial, Compounded by Wells Pharmacy,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 TriMix, Alprostadil/Phentolamine/Papaverine 100mcg/3mg/30mg/mL, (1 ML). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and… CGMP Deviations Gentell, Inc Terminated
Class II January 11, 2017 Testosterone Cypionate in Grapeseed Oil Injectable, 100 mg/mL, a) 1mL and b) 5 mL vials,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 L-Tyrosine 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Testosterone Enanthate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Chorionic Gonadotropin+B12(C), Lyophilized, 10,000 unit + 40 mcg Injectable Kit,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/1mg/30mg/mL, (1 ML). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 HCG/Hydroxycobalamin 5,000 IU/5 mg Vial. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Testosterone Cypionate in Sesame, 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 1… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Trimix with Atropine Injectable 30 mg/3 mg/60 mcg/0.2 mg/mL, 10 mL vial, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Mitomycin 20 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Nandrolone Decanoate 200 mg/ml, (5 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Sermorelin Acetate/GHRP (2)/Theanine 15 mg/5.4 mg/75 mg Injectable Kit, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Ascorbic Acid 500 mg/mL (50 ML). Compounded by Tri-Coast Pharmacy. Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 MIC Ultra Cocktail (Methionine (L) 25mg/Inositol 50mg/Choline Chloride… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable Kit,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Sermorelin Acetate/GHRP (6) 6 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Dexpanthenol 250 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 HCG 11,000 IU Vial. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Trimix Injectable 30 mg/2 mg/20 mcg, a) 5 mL and b) 10 mL vials, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 MIC/B-COMPLEX 15 mg/50 mg/100 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 mL vials,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto,… CGMP Deviations Apotex Corp. Terminated
Class II January 11, 2017 ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by Wells… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Inositol/Choline/B-Complex+Leucine+CARN+CHROM+LIDO (LipoLean), Injectable, 30 mL vial,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg). Compounded… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Dexamethasone Sodium Phosphate 200 mg/mL, Injectable, Compounded by Wells Pharmacy,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 MIC/B-COMP/(M)/CHROM/CARN, 20 mg/40 mg/50 mg/25 mcg/25 mg/mL Injectable, 30 mL vial,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL, (1 ML). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Lipo-C (Methionine 25 mg/Inositol 50 mg/Choline Chloride 50 mg/Carnitine (L) 100… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 MIC/B-COMP+CARN+LIDO, 15 mg/30 mg/30 mg/85 mg/20 mg/mL Injectable, 30 mL vial, Compounded… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial, Compounded by… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy Network,… Lack of Assurance of Sterility Wells Pharmacy Network LLC Terminated
Class II January 11, 2017 BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy. Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Methylcobalamin 1,000 mcg/mL, 10 mL and 30 mL. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/0.5mg/30mg/mL, (1 ML). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mg/ml, (1 ML).… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). Compounded by… Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class II January 11, 2017 L-Arginine HCL 100 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Tri-Coast Pharmacy Ongoing
Class III January 4, 2017 Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v… Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well… Care-Tech Laboratories, Inc. Terminated
Class II January 4, 2017 Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd.… CGMP Deviations Raritan Pharmaceuticals, Inc. Terminated
Class II January 4, 2017 CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed by: CVS… CGMP Deviations Raritan Pharmaceuticals, Inc. Terminated
Class III January 4, 2017 Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dietary… cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. VIRTUS PHARMACEUTICALS OPCO II L Terminated
Class III January 4, 2017 Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary… cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. VIRTUS PHARMACEUTICALS OPCO II L Terminated
Class III January 4, 2017 INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in… Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot… Cipher Pharmaceuticals US LLC Ongoing
Class III January 4, 2017 VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Acid and… cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. VIRTUS PHARMACEUTICALS OPCO II L Terminated
Class II January 4, 2017 Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by… Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT… Sandoz Incorporated Terminated
Class III January 4, 2017 Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary… cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. VIRTUS PHARMACEUTICALS OPCO II L Terminated
Class II January 4, 2017 CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy,… CGMP Deviations Raritan Pharmaceuticals, Inc. Terminated
Class I December 28, 2016 GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only,… Defective delivery system: detached needles on the syringe in the kit. Novo Nordisk Inc Terminated
Class I December 28, 2016 BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A… Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. Making It a Lifestyle Terminated
Class I December 28, 2016 Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite… Love My Tru Body Terminated
Class I December 28, 2016 Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only,… Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. VIRTUS PHARMACEUTICALS OPCO II L Terminated
Class II December 28, 2016 3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C. Marketed without an approved NDA/ANDA - presence of undeclared sibutramine. Making It a Lifestyle Terminated
Class I December 28, 2016 Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946… Non Sterility; contaminated with Klebsiella pneumoniae Sperian Eye & Face Protection, Inc Terminated
Class I December 28, 2016 Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing… Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs Impax Laboratories, Inc. Terminated
Class II December 28, 2016 Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta… Lack of Sterility Assurance Meta Pharmacy Services Terminated
Class I December 28, 2016 Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only,… Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. VIRTUS PHARMACEUTICALS OPCO II L Terminated
Class II December 28, 2016 Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by:… Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two… Inventia Healthcare Private Limited Terminated
Class III December 28, 2016 Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's… Labeling: Label Mix Up- Incorrect back label applied to the product. Les Emballages Knowlton Inc. Terminated
Class I December 28, 2016 BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C. Marketed without an approved NDA/ANDA - presence of undeclared sildenafil. Making It a Lifestyle Terminated
Class II December 28, 2016 C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ… Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized… Colonia Care Pharmacy Terminated
Class I December 28, 2016 Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured… Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a… Ultimate Body Tox Terminated
Class II December 28, 2016 C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy,… Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized… Colonia Care Pharmacy Terminated
Class I December 28, 2016 Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only,… Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. VIRTUS PHARMACEUTICALS OPCO II L Terminated
Class I December 28, 2016 Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL (… Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia US Compounding Inc Terminated
Class I December 28, 2016 Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country… Non-Sterility; microbial contamination identified as Bacillus circulans Town and Country Compounding and Consultation Services Terminated
Class I December 28, 2016 Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled… Non-Sterility: failed sterility test result. Guardian Pharmacy Services Terminated
Class III December 28, 2016 bupropion BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count… Failed Dissolution Specifications; 6 month time point Zydus Pharmaceuticals USA Inc Terminated
Class II December 28, 2016 KYPROLIS AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For… Lack of Assurance of Sterility: Potential cracks in glass vials Amgen, Inc. Terminated
Class I December 28, 2016 COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths… Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia. Sage Products LLC Terminated
Class II December 28, 2016 Fluconazole Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container… Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. Baxter Healthcare Corporation Terminated
Class II December 28, 2016 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into… CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated… Sage Products LLC Terminated
Class II December 28, 2016 COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths… CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated… Sage Products LLC Terminated
Class I December 28, 2016 Bupivacaine Hydrochloride Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose… Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial. Hospira Inc., A Pfizer Company Ongoing
Class II December 21, 2016 Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only, Rx Only,… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Calcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial, Rx Only,… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag,… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag,… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose Syringe, Rx… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syringe,… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only,… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe,… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Single-Dose… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag, Rx Only,… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Calcium Chloride (20 mg/mL) in 0.9% Sodium Chloride 500 mL Bag, Rx Only, Single-Dose Bag… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Heparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, Single-Dose… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class II December 21, 2016 Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co.… Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Cantrell Drug Company Terminated
Class III December 21, 2016 Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by… Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container… Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class II December 14, 2016 Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. North American Rescue LLC. Terminated
Class II December 14, 2016 Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. North American Rescue LLC. Terminated
Class II December 14, 2016 Amphibious Trauma Kit - Product Code 85-0639, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. North American Rescue LLC. Terminated
Class III December 14, 2016 Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only,… Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability… Teva Pharmaceuticals USA Terminated
Class II December 14, 2016 PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1… Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data. Fallon Wellness Pharmacy, L.L.C. Terminated
Class II December 14, 2016 Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744,… Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. North American Rescue LLC. Terminated
Class II December 14, 2016 K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301,… Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. North American Rescue LLC. Terminated
Class III December 14, 2016 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box,… Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf… Hospira Inc. Terminated
Class II December 14, 2016 USCG Boat Response Kit - Product Code 80-0353, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. North American Rescue LLC. Terminated
Class II December 14, 2016 Aid Backpack Kit - Product Code 85-0917, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. North American Rescue LLC. Terminated
Class II December 14, 2016 PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL… Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data. Fallon Wellness Pharmacy, L.L.C. Terminated
Class II December 14, 2016 Range Trauma Kit - Product Code 85-1274, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. North American Rescue LLC. Terminated
Class II December 14, 2016 Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. North American Rescue LLC. Terminated
Class III December 14, 2016 Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only,… Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability… Teva Pharmaceuticals USA Terminated
Class III December 14, 2016 Sodium Ferric Gluconate Complex in Sucrose SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL… Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing. West-Ward Pharmaceuticals Corp. Terminated
Class II December 7, 2016 URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg,… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Burel Pharmaceuticals Inc Terminated
Class II December 7, 2016 Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only,… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Burel Pharmaceuticals Inc Terminated
Class II December 7, 2016 Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR… Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container Par Pharmaceutical, Inc. Terminated
Class II December 7, 2016 UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Burel Pharmaceuticals Inc Terminated
Class II December 7, 2016 Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains:… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Burel Pharmaceuticals Inc Terminated
Class II December 7, 2016 Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains:… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Burel Pharmaceuticals Inc Terminated
Class II December 7, 2016 UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Burel Pharmaceuticals Inc Terminated
Class II December 7, 2016 AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg,… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Burel Pharmaceuticals Inc Terminated
Class II December 7, 2016 Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only,… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Burel Pharmaceuticals Inc Terminated
Class II December 7, 2016 Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only,… CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. Nationwide Laboratories, LLC Terminated
Class II December 7, 2016 Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b)… CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. Nationwide Laboratories, LLC Terminated
Class II December 7, 2016 Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only,… CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. Nationwide Laboratories, LLC Terminated
Class II December 7, 2016 Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b)… CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. Nationwide Laboratories, LLC Terminated
Class II December 7, 2016 Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar,… Microbial Contamination of Non-Sterile Product Cadila Pharmaceuticals Limited Terminated
Class II December 7, 2016 Metformin Hydrochloride Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem… Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin… Ascend Laboratories LLC Terminated
Class II November 30, 2016 Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes… Failed Stability Specifications; out-of specification value for homogeneity / phase separation. Akorn Inc Terminated
Class II November 30, 2016 Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only,… Lack of Assurance of Sterility: Complaints of broken tips on the ampules. Hospira Inc. Terminated
Class II November 30, 2016 LEVOXYL LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only,… Superpotent Pfizer Inc. Terminated
Class III November 30, 2016 AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual… Presence of Foreign Tablets/Capsules Amerisource Health Services Terminated
Class III November 30, 2016 NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed… Presence of Foreign Tablets/Capsules Actavis Elizabeth LLC Terminated
Class III November 30, 2016 Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01),… Failed Impurities/Degradation Specifications: OOS results for known compound. Mylan Pharmaceuticals Inc. Terminated
Class III November 30, 2016 KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147… Failed Stability Specifications: Low Out of Specification results for alcohol content. Sun Pharmaceutical Industries, Inc. Terminated
Class III November 30, 2016 bupropion BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count… Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point. Zydus Pharmaceuticals USA Inc Terminated
Class II November 30, 2016 Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward… Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month… West-Ward Pharmaceuticals Corp. Terminated
Class III November 30, 2016 Amoxicillin Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only,… Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is… West-Ward Pharmaceuticals Corp. Terminated
Class II November 30, 2016 Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in… Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria,… VistaPharm, Inc. Terminated
Class III November 30, 2016 Ceftriaxone Sodium Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use,… Labeling: Missing Label Sandoz Inc Terminated
Class II November 23, 2016 L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial… Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product… Sandoz Inc Terminated
Class III November 23, 2016 FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only,… Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert… CutisPharma, Inc. Terminated
Class III November 23, 2016 Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g),… Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of… GSK Consumer Healthcare Terminated
Class III November 23, 2016 Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle… Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on… Amerisource Health Services Terminated
Class III November 23, 2016 FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only,… Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert… CutisPharma, Inc. Terminated
Class II November 23, 2016 L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC… Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product… Sandoz Inc Terminated
Class III November 16, 2016 Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Wells Pharmacy Network, LLC Terminated
Class II November 16, 2016 Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Wells Pharmacy Network, LLC Terminated
Class III November 16, 2016 Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Wells Pharmacy Network, LLC Terminated
Class III November 16, 2016 Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10… Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a… Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class II November 16, 2016 Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Wells Pharmacy Network, LLC Terminated
Class II November 16, 2016 Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Wells Pharmacy Network, LLC Terminated
Class III November 16, 2016 Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10… Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a… Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class III November 16, 2016 Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis… Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione. Taro Pharmaceuticals U.S.A., Inc. Terminated
Class III November 16, 2016 Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Wells Pharmacy Network, LLC Terminated
Class III November 16, 2016 Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Wells Pharmacy Network, LLC Terminated
Class II November 16, 2016 Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only,… Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following… Sandoz Inc Terminated
Class III November 9, 2016 Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg,… Subpotent Drug; Ethinyl Estradiol Par Pharmaceutical, Inc. Completed
Class II November 9, 2016 Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only,… Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media… Pharmedium Services, LLC Terminated
Class III November 9, 2016 Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm… Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather… Actavis Laboratories, FL, Inc. Ongoing
Class II November 9, 2016 Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc.,… Subpotent Drug: concentration of product is less than labeled amount. Akorn Inc Terminated
Class III November 9, 2016 Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP),… Subpotent Drug; Ethinyl Estradiol Par Pharmaceutical, Inc. Completed
Class III November 9, 2016 Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP… Subpotent Drug; Ethinyl Estradiol Par Pharmaceutical, Inc. Completed
Class III November 9, 2016 Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg,… Subpotent Drug; Ethinyl Estradiol Par Pharmaceutical, Inc. Completed
Class III November 9, 2016 Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg,… Subpotent Drug; Ethinyl Estradiol Par Pharmaceutical, Inc. Completed
Class II November 9, 2016 Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc.… Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation). Taro Pharmaceuticals, Inc. Terminated
Class II November 9, 2016 Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc.… Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation). Taro Pharmaceuticals, Inc. Terminated
Class II November 2, 2016 DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane… Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50… Boehringer Ingelheim Pharmaceuticals, Inc. Terminated
Class II November 2, 2016 Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by:… Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50… Boehringer Ingelheim Pharmaceuticals, Inc. Terminated
Class III November 2, 2016 INVOKAMET Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx… Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior… Janssen Ortho L.L.C. Terminated
Class I October 26, 2016 Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20… Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to… Arbor Pharmaceuticals Inc. Terminated
Class III October 26, 2016 PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics… Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. Teva Pharmaceuticals USA Terminated
Class III October 26, 2016 PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics… Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. Teva Pharmaceuticals USA Terminated
Class I October 26, 2016 Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box. Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its… SOS Telecom Inc. Terminated
Class II October 26, 2016 Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle Marketed without an approved NDA/ANDA: Undeclared sibutramine. Dream Body Weight Loss Terminated
Class III October 26, 2016 PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics… Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. Teva Pharmaceuticals USA Terminated
Class I October 26, 2016 Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box. Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its… SOS Telecom Inc. Terminated
Class II October 26, 2016 Dream Body Advanced 400 mg 30 capsules in brown foil packets. Marketed without an approved NDA/ANDA: Undeclared sibutramine. Dream Body Weight Loss Terminated
Class II October 26, 2016 Dream Body 450 mg 30 capsules in a plastic screw on top bottle Marketed without an approved NDA/ANDA: Undeclared sibutramine. Dream Body Weight Loss Terminated
Class I October 26, 2016 Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its… SOS Telecom Inc. Terminated
Class I October 26, 2016 Ninja-X, 4200 mg, 1 capsule per pack, 24 single packs per box. Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its… SOS Telecom Inc. Terminated
Class II October 26, 2016 Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only,… Superpotent Drug: Failure of assay specifications in the capsule. Supernus Pharmaceuticals, Inc. Terminated
Class II October 19, 2016 lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product code 2R3441,… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Preservative… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL… Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters Leiter's Compounding Terminated
Class II October 19, 2016 PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL, in 0.9% Sodium Chloride, Preservative… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample… Failed Content Uniformity Specifications Allergan Sales, LLC Terminated
Class II October 19, 2016 fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium,… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary… CGMP Deviations Teva Pharmaceuticals USA Terminated
Class II October 19, 2016 lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, PharMEDium,… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a syringe,… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Preservative… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe,… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syringe, Rx… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class III October 19, 2016 Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC… Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed… Amerisource Health Services Terminated
Class II October 19, 2016 Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride,… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL… Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters Leiter's Compounding Terminated
Class II October 19, 2016 HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe,… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a syringe, NOT… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class I October 19, 2016 La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for… Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein Bee Xtreme Terminated
Class II October 19, 2016 atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class I October 19, 2016 Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL)… Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia The Harvard Drug Group Terminated
Class II October 19, 2016 Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by… Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters Leiter's Compounding Terminated
Class II October 19, 2016 neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe,… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in… Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class I October 19, 2016 Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless… Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein Bee Xtreme Terminated
Class II October 19, 2016 ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total Volume in… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated
Class II October 19, 2016 morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Pharmedium Services, LLC Terminated