OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data

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 August 5, 2020 Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond… Lack of Processing Controls (lack of assurance of conformity to specifications). MasterPharm LLC Terminated
Class II August 5, 2020 Estriol 6 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond… Lack of Processing Controls (lack of assurance of conformity to specifications). MasterPharm LLC Terminated
Class II August 5, 2020 Progesterone Modified Release 100 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02… Lack of Processing Controls (lack of assurance of conformity to specifications). MasterPharm LLC Terminated
Class II August 5, 2020 Yohimbine HCL 5.4mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave,… Lack of Processing Controls (lack of assurance of conformity to specifications). MasterPharm LLC Terminated
Class II August 5, 2020 Tadalafil 3 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond… Lack of Processing Controls (lack of assurance of conformity to specifications). MasterPharm LLC Terminated
Class II August 5, 2020 Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by… CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared… POLARIZED LLC Terminated
Class II August 5, 2020 Tadalafil 7 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond… Lack of Processing Controls (lack of assurance of conformity to specifications). MasterPharm LLC Terminated
Class II August 5, 2020 Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle,… Lack of Processing Controls (lack of assurance of conformity to specifications). MasterPharm LLC Terminated
Class II August 5, 2020 Progesterone 50 mg Modified Release Capsule, 90 capsules per bottle, MasterPharm, 115-02… Lack of Processing Controls (lack of assurance of conformity to specifications). MasterPharm LLC Terminated
Class II August 5, 2020 Finasteride Plus 1.25mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave,… Lack of Processing Controls (lack of assurance of conformity to specifications). MasterPharm LLC Terminated
Class III August 5, 2020 Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl… SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. Allergan PLC Terminated
Class II August 5, 2020 D-Biotin 300 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave,… Lack of Processing Controls (lack of assurance of conformity to specifications). MasterPharm LLC Terminated
Class III August 5, 2020 Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg… Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity… SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II July 29, 2020 Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz and 16 oz,… Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved… WALKER EMULSIONS INC Terminated
Class II July 29, 2020 Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1… Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved… WALKER EMULSIONS INC Terminated
Class III July 29, 2020 Famotidine Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For… TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state. HF Acquisition Co. LLC Terminated
Class I July 29, 2020 Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antiseptic Hand Rub,… Chemical Contamination: Presence of Undeclared Methanol Transliquid Technologies, LLC Terminated
Class II July 29, 2020 Cefdinir Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only,… Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples. Lupin Pharmaceuticals Inc. Terminated
Class II July 22, 2020 Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical… CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the… Preferred Pharmaceuticals, Inc. Terminated
Class III July 22, 2020 Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle,… Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample Akorn, Inc. Terminated
Class II July 22, 2020 Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by:… FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability… RemedyRepack Inc. Terminated
Class III July 22, 2020 Fosaprepitant Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only,… Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of… Fresenius Kabi USA, LLC Terminated
Class II July 22, 2020 Metformin Hydrochloride Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only,… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Lupin Pharmaceuticals Inc. Terminated
Class II July 22, 2020 Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured… cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for… Keryx Biopharmaceuticals, Inc. Terminated
Class II July 22, 2020 Metformin Hydrochloride Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only,… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Lupin Pharmaceuticals Inc. Terminated
Class II July 22, 2020 Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only,… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Lupin Pharmaceuticals Inc. Terminated
Class II July 22, 2020 Metformin Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Granules Pharmaceuticals Inc Ongoing
Class II July 22, 2020 Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only,… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Lupin Pharmaceuticals Inc. Terminated
Class III July 15, 2020 Brimonidine Tartrate Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for:… Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle… SOMERSET THERAPEUTICS LLC Terminated
Class III July 15, 2020 Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle… Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification. VistaPharm, Inc. Terminated
Class III July 15, 2020 Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured… Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification. VistaPharm, Inc. Terminated
Class III July 15, 2020 TECFIDERA Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only,… cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control. Biogen MA Inc. Terminated
Class III July 15, 2020 Brimonidine Tartrate Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for:… Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle… SOMERSET THERAPEUTICS LLC Terminated
Class III July 15, 2020 Brimonidine Tartrate Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for:… Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle… SOMERSET THERAPEUTICS LLC Terminated
Class II July 15, 2020 Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use… Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to… EMD Serono, Inc. Terminated
Class II July 8, 2020 Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%),… Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl… Beaming White Llc Terminated
Class II July 8, 2020 Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake… Preferred Pharmaceuticals, Inc. Terminated
Class II July 8, 2020 Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%),… Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl… Beaming White Llc Terminated
Class II July 8, 2020 Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL),… Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. Glaxosmithkline Consumer Healthcare Holdings Terminated
Class I July 8, 2020 Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a… Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin. MasterPharm LLC Terminated
Class III July 8, 2020 Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial,… Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead… Flexion Therapeutics, Inc. Terminated
Class II July 8, 2020 Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit… CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels. The Harvard Drug Group Terminated
Class II July 8, 2020 Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%),… Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl… Beaming White Llc Terminated
Class II July 8, 2020 Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough… Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. Glaxosmithkline Consumer Healthcare Holdings Terminated
Class II July 1, 2020 Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only,… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Lupin Pharmaceuticals Inc. Terminated
Class III July 1, 2020 R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50… Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac QuVa Pharma, Inc. Terminated
Class II July 1, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by:… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Amneal Pharmaceuticals of New York, LLC Ongoing
Class II July 1, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01)… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Teva Pharmaceuticals USA Terminated
Class II July 1, 2020 Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and… BIOTA Biosciences LLC Terminated
Class III July 1, 2020 Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister… Failed Dissolution Specifications Pfizer Inc. Terminated
Class II July 1, 2020 Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and… BIOTA Biosciences LLC Terminated
Class III July 1, 2020 Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards),… Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not… American Health Packaging Terminated
Class II July 1, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Amneal Pharmaceuticals of New York, LLC Ongoing
Class II July 1, 2020 Sterile Curcumin 50mg/mL, 10 mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and… BIOTA Biosciences LLC Terminated
Class II July 1, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Amneal Pharmaceuticals of New York, LLC Ongoing
Class II July 1, 2020 Sterile Curcumin, 4mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and… BIOTA Biosciences LLC Terminated
Class II July 1, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Amneal Pharmaceuticals of New York, LLC Ongoing
Class II July 1, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Amneal Pharmaceuticals of New York, LLC Ongoing
Class II July 1, 2020 Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and… BIOTA Biosciences LLC Terminated
Class II July 1, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Amneal Pharmaceuticals of New York, LLC Ongoing
Class II July 1, 2020 Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Teva Pharmaceuticals USA Terminated
Class II July 1, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Amneal Pharmaceuticals of New York, LLC Ongoing
Class II July 1, 2020 Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P.… cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications. A.P. Deauville, LLC Terminated
Class II July 1, 2020 amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles,… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Amneal Pharmaceuticals of New York, LLC Ongoing
Class II July 1, 2020 Metformin Hydrochloride amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Amneal Pharmaceuticals of New York, LLC Ongoing
Class II July 1, 2020 Metformin Hydrochloride amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Amneal Pharmaceuticals of New York, LLC Ongoing
Class II July 1, 2020 Metformin Hydrochloride amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Amneal Pharmaceuticals of New York, LLC Ongoing
Class II July 1, 2020 Aripiprazole Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic… Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count. Alembic Pharmaceuticals Limited Terminated
Class II July 1, 2020 Metformin Hydrochloride amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Amneal Pharmaceuticals of New York, LLC Ongoing
Class II July 1, 2020 CLOZAPINE Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo… Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of… Aurobindo Pharma USA Inc. Terminated
Class II July 1, 2020 Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and… Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. Crown Laboratories Terminated
Class II July 1, 2020 Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and… Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. Crown Laboratories Terminated
Class II July 1, 2020 METFORMIN HYDROCHLORIDE EXTENDED RELEASE Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Marksans Pharma Limited Terminated
Class II July 1, 2020 METFORMIN HYDROCHLORIDE EXTENDED RELEASE metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level PD-Rx Pharmaceuticals, Inc. Terminated
Class III July 1, 2020 timolol maleate Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical… Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for… Rising Pharmaceuticals, Inc. Terminated
Class III July 1, 2020 timolol maleate Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical… Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for… Rising Pharmaceuticals, Inc. Terminated
Class II June 24, 2020 EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net… Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the… Eco Lips Inc Terminated
Class II June 24, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA… Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. SCA Pharmaceuticals Terminated
Class II June 24, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level AVKARE Inc. Terminated
Class II June 24, 2020 metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC:… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level PD-Rx Pharmaceuticals, Inc. Terminated
Class II June 24, 2020 Irinotecan Hydrochloride Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by:… Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. Hikma Pharmaceuticals USA Inc. Terminated
Class II June 24, 2020 Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL),… Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. Glaxosmithkline Consumer Healthcare Holdings Terminated
Class II June 24, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level AVKARE Inc. Terminated
Class II June 24, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels Apotex Inc. Completed
Class III June 24, 2020 Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco… Failed Impurities/ Degradation Specifications Aurobindo Pharma USA Inc. Terminated
Class III June 24, 2020 Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco… Failed Impurities/ Degradation Specifications Aurobindo Pharma USA Inc. Terminated
Class II June 24, 2020 Irinotecan Hydrochloride Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by:… Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. Hikma Pharmaceuticals USA Inc. Terminated
Class II June 24, 2020 Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distributed by: GSK… Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. Glaxosmithkline Consumer Healthcare Holdings Terminated
Class II June 24, 2020 Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by:… Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. Glaxosmithkline Consumer Healthcare Holdings Terminated
Class II June 24, 2020 Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin… Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. Glaxosmithkline Consumer Healthcare Holdings Terminated
Class III June 17, 2020 Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH… Discoloration: Out of Specification (OOS) result for APHA Color Test. Akorn, Inc. Terminated
Class II June 17, 2020 oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV… Subpotent drug - Product did not contain drug. QuVa Pharma, Inc. Terminated
Class I June 17, 2020 KETOROLAC TROMETHAMINE Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials… Presence of Particulate Matter - found in reserve sample vials at the firm. Fresenius Kabi USA, LLC Terminated
Class II June 17, 2020 KETOROLAC TROMETHAMINE Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL… Presence of Particulate Matter - found in reserve sample vials at the firm. Fresenius Kabi USA, LLC Terminated
Class III June 17, 2020 Clonidine Hydrochloride Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by:… Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product… UNICHEM PHARMACEUTICALS USA INC Terminated
Class II June 17, 2020 Lisinopril Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin… Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle. Lupin Pharmaceuticals Inc. Terminated
Class II June 17, 2020 Doxycycline Hyclate Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only,… Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf… American Health Packaging Terminated
Class II June 17, 2020 UNASYN Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10… Presence of Particulate Matter: particulate matter identified after reconstitution. Pfizer Inc. Terminated
Class III June 10, 2020 Lamotrigine Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500… Presence of Foreign Substance consistent with granules from desiccant packs used during storage AVKARE Inc. Terminated
Class II June 10, 2020 Carbamazepine Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured… Failed Dissolution Specifications Torrent Pharma Inc. Terminated
Class II June 10, 2020 Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103,… Failed impurities/ degradation specifications: Out of specification for organic impurities. TRIOVA PHARMACEUTICALS LLC Terminated
Class II June 10, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and… Some bottles may contain mixed strengths of the product. Teva Pharmaceuticals USA Terminated
Class II June 10, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and… Some bottles may contain mixed strengths of the product. Teva Pharmaceuticals USA Terminated
Class II June 10, 2020 Doxycycline Hyclate Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC… Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an… The Harvard Drug Group Terminated
Class I June 10, 2020 NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only,… Superpotent Drug. Acella Pharmaceuticals, LLC Terminated
Class I June 10, 2020 NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only,… Superpotent Drug. Acella Pharmaceuticals, LLC Terminated
Class I June 10, 2020 NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only,… Superpotent Drug. Acella Pharmaceuticals, LLC Terminated
Class II June 10, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and… Some bottles may contain mixed strengths of the product. Teva Pharmaceuticals USA Terminated
Class II June 3, 2020 LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box,… CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance… Wuhan Bingbing Pharmaceutical Co., Ltd. Ongoing
Class II June 3, 2020 Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per… CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance… Wuhan Bingbing Pharmaceutical Co., Ltd. Ongoing
Class II June 3, 2020 Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain… CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance… Wuhan Bingbing Pharmaceutical Co., Ltd. Ongoing
Class III June 3, 2020 Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant… Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized… Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class II June 3, 2020 Doxycycline Hyclate Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC… Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of… West-Ward Columbus Inc Terminated
Class II June 3, 2020 LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box… CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance… Wuhan Bingbing Pharmaceutical Co., Ltd. Ongoing
Class II June 3, 2020 Doxycycline Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC… Failed dissolution specifications PD-Rx Pharmaceuticals, Inc. Terminated
Class III May 27, 2020 Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward… Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants. West-Ward Columbus Inc Terminated
Class III May 27, 2020 Gabapentin Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan… Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing. InvaGen Pharmaceuticals, Inc. Terminated
Class I May 27, 2020 LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake… Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron… ICU Medical Inc Terminated
Class II May 27, 2020 Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only,… Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of… Mylan Institutional LLC Terminated
Class I May 20, 2020 Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded… Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil. MasterPharm LLC Terminated
Class III May 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g)… Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card Glaxosmithkline Consumer Healthcare Holdings Terminated
Class III May 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g)… Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card Glaxosmithkline Consumer Healthcare Holdings Terminated
Class III May 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g)… Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card Glaxosmithkline Consumer Healthcare Holdings Terminated
Class III May 20, 2020 memantine hydrochloride Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose… Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing. The Harvard Drug Group Terminated
Class II May 13, 2020 Epinephrine Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx… CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that… Teva Pharmaceuticals USA Terminated
Class II May 13, 2020 Infuvite Pediatric Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL)… Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins Sandoz, Inc Terminated
Class I May 6, 2020 Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex… Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers. B. Braun Medical Inc Terminated
Class III May 6, 2020 Esomeprazole Magnesium Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only,… Discoloration: product contains brown pellets Dr. Reddy's Laboratories, Inc. Terminated
Class II May 6, 2020 Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed… CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. Amneal Pharmaceuticals of New York, LLC Terminated
Class II April 29, 2020 Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin… Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20… Lupin Pharmaceuticals Inc. Terminated
Class II April 29, 2020 PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube,… Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient… Yusef Manufacturing Laboratories, LLC Terminated
Class II April 29, 2020 CEFIXIME Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin… Subpotent Drug: low out of specification (OOS) test result observed in long term stability study. Lupin Pharmaceuticals Inc. Terminated
Class II April 29, 2020 Daytrana Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr)… Defective Delivery System: Out of specification for mechanical peel and shear. Noven Therapeutics, LLC Terminated
Class II April 29, 2020 Daytrana Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr)… Defective Delivery System: Out of specification for mechanical peel and shear. Noven Therapeutics, LLC Terminated
Class II April 29, 2020 Daytrana Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr),… Defective Delivery System: Out of specification for mechanical peel and shear. Noven Therapeutics, LLC Terminated
Class II April 22, 2020 Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC… cGMP deviations: Presence of foreign material (Teflon)introduced at the production level. B & B Pharmaceuticals, Inc. Terminated
Class II April 22, 2020 Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct.… CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used… Golden State Medical Supply Inc. Terminated
Class II April 22, 2020 Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL bottle, Rx,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est (8:2)/Progesterone/Testosterone 0.5/75 mg per 0.2 mL Cream 6 mL jar, Rx, The… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est (50/50/Progesterone 0.2 mg/70 mg Cream 30 gm jar, Rx, The Medicine Shoppe… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Hydrocortisone in Aquaphor/Therapeutic Moisturizing Cream 100 gm tube, Rx, The Medicine… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Estradiol Vag Cream 0.01% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Naltrexone (Loxoral) 4.5 mg Capsules, 60 count bottle, Rx, The Medicine Shoppe Pharmacy,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy, Port… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Estradiol 1.8 mg capsule 30 cap bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Estradiol/Progesterone/Testosterone 1.5/100/1.25 mg/mL Cream 30 gm tube, Rx, The Medicine… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est 1:1/Progesterone/Testosterone 1mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM tube, Rx, The Medicine… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion… Microbial contamination of non-sterile products: positive test for yeast and bacteria. Filltech USA, LLC Terminated
Class II April 22, 2020 Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion… Microbial contamination of non-sterile products: positive test for yeast and bacteria. Filltech USA, LLC Terminated
Class II April 22, 2020 Progesterone/Versa Base 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est 8:2/Progesterone/Testosterone DHEA 4.0/100/1/25.0 mg capsules 90 capsules bottle,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est 1:1/Progesterone/Testosterone 2.0/100/0.25 mg/mL Cream 30 gm tube, Rx, The… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est (8:2) Progest/Test 2/80/3 mg/mL cream 30 gm tube, Rx, The Medicine Shoppe… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Estriol Vaginal Cream (0.1%) 1 mg Cream 30 GM tubes, Rx, The Medicine Shoppe Pharmacy,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository (Pink) 48 suppositories, Rx,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Estriol 5 mg Suppository 36 each box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Testosterone W/Cosmetic HRT Base 100 MG (10%) Cream 30 GM, tubes Rx, The Medicine Shoppe… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Levothyroxin (T4)/Liothyronine (T3) SR 130 mg/175 mg capsule 21 capsules bottle, Rx, The… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est (50/50)/Progesterone/Testosterone 1.5 mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Diethylstilbestrol 1 mg capsule 300 capsules bottle, Rx, The Medicine Shoppe Pharmacy,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Testosterone w/Cosmetic HRT Base 20 mg (2%) Cream 30 GM jar, Rx, The Medicine Shoppe… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est (8:2)/Progesterone 2/100 mg/mL capsule 90 caps bottle, Rx, The Medicine Shoppe… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est (1:1)/Progesterone/Testosterone 2.0 mg/40 mg/1.0 mg/mL Cream 30 gm tube, Rx, The… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Testosterone w/ Atrevis 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Paregoric Compound (contains Morphine) Solution 480 mL bottle, Rx, The Medicine Shoppe… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est (1:1) Progesterone/Testost 1.0 mg/60 mg/0.5 mg/mL Cream 60 gm tube, Rx, The… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est (8:2)/DHEA/Testosterone 0.8 mg/ 9/0.4 mg/0.2 mg/mL Cream 6 gm tube, Rx, The… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Ergotamine Tartrate 1 mg/Caffeine 100 mg Base Suppository (Pink) 48 count box, Rx, The… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est (1:1) Progest/Test 0.5 mg/1.5 mg/mL cream 60 gm tube, Rx, The Medicine Shoppe… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Testosterone in Atrevis 50 mg/mL Gel 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Paregoric Alternate Elixir 300 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Testosterone in Atrevis 75 mg/mL Gel 90 GMS tube, Rx, The Medicine Shoppe Pharmacy, Port… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube, Rx, The… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar, Rx, The Medicine Shoppe… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Testosterone w/ Atrevis 100 mg/mL GEL, 90 gm pump, Rx, The Medicine Shoppe Pharmacy, Port… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Naltrexone 4.5 mg/mL Suspension 30 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est 8:2/Progesterone 2.5 mg/150/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est (50/50)/Progesterone 1.25 mg/80 mL Cream 30 gm tube, Rx, The Medicine Shoppe… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est (1:1) Progest/Test 0.5 mg/40 mg/10.5 mg/mL Cream 30 gm tube, Rx, The Medicine… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM, tube Rx, The Medicine… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar, Rx, The Medicine Shoppe Pharmacy, Port… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube, Rx, The… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Clobetasol Mouth Rinse 0.05% Solution 450 mL bottle, Rx, The Medicine Shoppe Pharmacy,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Progesterone/Natacream 20 mg/2% mL Cream 60 gm jar, Rx, The Medicine Shoppe Pharmacy,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Betahistine 16 mg Capsule 180 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est (8:2)/Progest/Test/DHEA 6/50/0.5/10 mg/mL Cream 30 mL, Rx, The Medicine Shoppe… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est 1:1/Progest/DHEA 1/40/5 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Hydromorphone Oral 1 mg/mL Solution 240 mL, bottle, Rx, The Medicine Shoppe Pharmacy,… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Progesterone 200 mg Capsules 90 capsules, Rx, The Medicine Shoppe Pharmacy, Port… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Bi-Est (50/50)/Progesterone/Testost 1.5/100/0.5 mg Cream 30 gm tube, Rx, The Medicine… Lack of Processing Control The Medicine Shoppe Pharmacy Terminated
Class II April 22, 2020 Phentermine Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by:… CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Aurobindo Pharma USA Inc. Terminated
Class II April 22, 2020 Levetiracetam Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo… CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Aurobindo Pharma USA Inc. Terminated
Class II April 22, 2020 Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle… cGMP Deviations H J Harkins Company Inc dba Pharma Pac Terminated
Class II April 22, 2020 Gabapentin Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo… CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Aurobindo Pharma USA Inc. Terminated
Class II April 22, 2020 Mirtazapine Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo… CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Aurobindo Pharma USA Inc. Terminated
Class II April 22, 2020 acetaminophen and codeine phosphate Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx… CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Aurobindo Pharma USA Inc. Terminated
Class II April 22, 2020 Simvastatin Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma… CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Aurobindo Pharma USA Inc. Terminated
Class II April 22, 2020 acetaminophen and codeine phosphate Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx… CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Aurobindo Pharma USA Inc. Terminated
Class II April 22, 2020 Oxycodone and Acetaminophen Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only,… CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Aurobindo Pharma USA Inc. Terminated
Class II April 22, 2020 acetaminophen and codeine phosphate Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx… CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Aurobindo Pharma USA Inc. Terminated
Class II April 15, 2020 rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium… Firm is recalling 46 lots of various products because of a lack of sterility assurance. PharMEDium Services, LLC Terminated
Class II April 15, 2020 Detoxin-S, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Pain Away, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Worm Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Hair Back Lotion, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Thyro-H, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Lipidtrol, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx… Lack of Assurance of Sterility Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy Terminated
Class II April 15, 2020 Herpes V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Nasal Ez, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Fungo Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Acne Cystic, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Tution 130, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Metabolic Booster. 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Fungo Lotion, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Sweat Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Herpes V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE… Lack of Assurance of Sterility Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy Terminated
Class II April 15, 2020 Herpes-G, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Vertigo Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Skin Lift Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Voice Rescue, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Sugar Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Sperm Booster, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Cellulite Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Bleeding Stop, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Herpes-G, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Lump Shrinker, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Dermamycin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Herpes Soap, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Stomach Cleanser, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Age Back, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Flare Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 DeTensin Ex, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Immune-2100, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Dragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Purple Gold Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Skin Cleanser, 500mg Capsules, 90-count bottles2, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Herpes-P, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Dermatoxin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE… Lack of Assurance of Sterility Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy Terminated
Class II April 15, 2020 Phlegm Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Skin De-Tag, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… Avet Pharmaceuticals, Inc. Terminated
Class II April 15, 2020 Acupuncture, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 Vitiligo Off Ointment, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 BioMycin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated