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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 July 6, 2022 Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass… Defective container: defect prevents product from dispensing as intended. Akorn, Inc. Terminated
Class II July 6, 2022 Losartan Potassium Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits PD-Rx Pharmaceuticals, Inc. Terminated
Class I July 6, 2022 SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012,… Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial… Green Pharmaceuticals, Inc. Terminated
Class II July 6, 2022 Daytrana Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr)… Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer. Noven Pharmaceuticals Inc Ongoing
Class II July 6, 2022 Losartan Potassium Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits PD-Rx Pharmaceuticals, Inc. Terminated
Class II July 6, 2022 Losartan Potassium Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits PD-Rx Pharmaceuticals, Inc. Terminated
Class I July 6, 2022 Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Subcutaneous… Superpotent: High Out of specification (OOS) test result for percent label claim (%LC). Akcea Therapeutics, Inc. Terminated
Class II July 6, 2022 losartan potassium and hydrochlorothiazide Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC #… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Macleods Pharma Usa Inc Terminated
Class II June 29, 2022 Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun… Failed Tablet/Capsule Specification; oversized tablet found in a bottle SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II June 29, 2022 Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA… Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution. Teva Pharmaceuticals USA Inc Terminated
Class II June 29, 2022 CLONIDINE Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton… Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability… Mayne Pharma Inc Terminated
Class II June 29, 2022 70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US with US… Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects… Vi-Jon, LLC Terminated
Class II June 29, 2022 Testosterone Cypionate Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx… Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II June 29, 2022 Testosterone Cypionate Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx… CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to… SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class I June 22, 2022 Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor… Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved… Walmart Inc Completed
Class II June 22, 2022 Syphilinum, Potency: 9C, 30C, 200C, 10X, 12X, Liquid Pellets, Rx only, Washington… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washington… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Diphtherinum, Potency: 14C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington Homeopathic… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged… CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. A.P. Nonweiler Ongoing
Class II June 22, 2022 Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Pertussinum, Potency: 19C, 30C, 200C, 1M, Liquid Pellets, OTC, Washington Homeopathic… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles;… Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol. AMS Packaging Inc Ongoing
Class II June 22, 2022 Anthracinum, Potency: 6C, 7C, 8C, 9C, 12C, 14C, 30C, 200C, 11X, 14X, 30X Liquid Pellets,… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Proteus, Potency: 7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, 200C, OTC, Liquid Pellets,… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Pyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, OTC, Liquid… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for… Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term… Lupin Pharmaceuticals Inc. Terminated
Class II June 22, 2022 Tuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets, Rx only, Washington… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, Washington… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Morbillinum, Potency:7C, 8C, 9C, 10C 12C, 13C, 15C, 20C, 21C, 30C, 200 C,Liquid Pellets,… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington Homeopathic… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Streptococcinum, Potency: 8C, 9C, 30C, 200C, Liquid Pellets, Rx only, Washington… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Candida Albicans, Potency: 9C, 10C, 12C, 13C, 14C 15C 16C, 19C, 24C, 25C, 26C, 30C, 200C,… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Influenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C, 12C, 30C 1M, Liquid Pellets,… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15C, 25C, 30C,… cGMP deviations Washington Homeopathic Products, Inc. Terminated
Class II June 22, 2022 Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled… Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims. Walmart Inc Completed
Class II June 22, 2022 medroxyprogesterone acetate medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150… Lack of assurance of sterility SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II June 22, 2022 medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL,… Lack of assurance of sterility SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II June 22, 2022 medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150… Lack of assurance of sterility SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II June 22, 2022 Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bottles, UPC 7… Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims. Walmart Inc Completed
Class II June 22, 2022 medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150… Lack of assurance of sterility SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II June 22, 2022 medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150… Lack of assurance of sterility SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II June 22, 2022 HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution,… CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. Hand Sanitizer LLC Terminated
Class III June 15, 2022 Xiidra Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12… Failed Impurities/Degradation Specifications. Novartis Pharmaceuticals Corporation Terminated
Class III June 15, 2022 Xiidra Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5… Failed Impurities/Degradation Specifications. Novartis Pharmaceuticals Corporation Terminated
Class II June 15, 2022 Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: Major… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Loperamide Hydrochloride Loperamide Hydrochloride capsules, USP, 2 mg, 100-count bottle, Rx only, MFG: Mylan… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class I June 15, 2022 Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication.,… Subpotent drug Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy Terminated
Class I June 15, 2022 Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication.,… Subpotent drug Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy Terminated
Class II June 15, 2022 Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy,… Microbial contamination of non-sterile product. Grato Holdings, Inc. Terminated
Class II June 15, 2022 Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset Therapeutics,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 MethyLPREDNISolone Acetate Injectable Suspension, USP, 400 mg/10 mL (40 mg/mL), 10 mL… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Paracentesis/Thoracentises Tray (10/cs) Rx CRFPED, Lidocaine Hydrochloride USP, 1%, 5mL,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Sumatriptan Injection, USP, 6mg/0.5 mL, packaged in a box of 5 x 0.5 mL single-dose… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 MIOSTAT (Carbachol Intraocular Solution, USP) 0.01%, 1.5 mL, Rx only, MFG: Alcon Surgical… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, Rx only,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL single-dose… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Intralipid Intralipid (I.V. Fat emulsion), 20%, 250 mL bag, Rx only, MFG: Baxter Healthcare, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Ciprofloxacin Ophthalmic Solution 0.3%, 10 mL bottle, Rx only, Manufactured by: Alcon… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Manufacturer:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Biopsy and Aspiration Tray Bone Marrow Illinois 11GX4 (10/cs) Rx CRFPED Lidocaine… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) 50 mL vial,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Epinephrine, ABJT 0.1 mg/mL, 10 mL, 20GX1.5 (10 pack), Rx only, MFG: Pfizer, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Thrombin JMI, Vial 5,000IU 2/diluent, kit, Rx only, MFG: Pfizer NDC 60793-215-05 cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Metoprolol tablets 50 mg, 100-count botte, Rx only, MFG: Sun Pharmaceuticals, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), packaged in a kit,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), Rx only,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Tropicamide Ophthalmic Solution, USP 1%, 3 mL bottle, Rx only, MFG: Sandoz Pharma, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Epidural Tray, Nerve Block Single shot, Rx only, # 182207, MFG: Avanos Medical Sales LLC cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Intralipid Intralipid (I.V. Fat emulsion), 20%, 100 mL bag, Rx only, MFG: Baxter Healthcare, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) single… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-five 20 mL… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class III June 15, 2022 Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only,… Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine… Teva Pharmaceuticals USA Inc Terminated
Class II June 15, 2022 Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manufacturer:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, Manufacturer:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 MethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in a) 1 mL… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL vials, packaged… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL, Rx only,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Verapamil HCL, ampule, 2.5 mg/ML 2ML (5/pack), Rx only, MFG: Pfizer, NDC 04094-011-01 cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Arzol (Silver Nitrate Applicator), (Silver Nitrate 75%, Potassium Nitrate 25%), 100-count… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial, 10-count box, Rx only, MFG: Teva… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL, Rx only,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC 0536-1047-10 cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Levalbuterol tartrate HFA inhalation Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Olanzapine single dose vial Lyophilized, 10 mg, Rx only, MFG: Auromedics Pharma LLC, NDC#… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Lidocaine Patch, 5%, 30-count box, Rx only, Manufacturer: Rhodes Pharmaceuticals, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Tetracaine Hydrochloride Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG: Alcon… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, MFG: Bracco… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%, 10 mL… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Ciprofloxacin Hydrochloride Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalations, Rx only,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Celestone Soluspan (betamethasone sodium phosphate and betametasone acetate injectable… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 metered… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Xylocaine - MPF (lidocaine HCl and epinephrine injection, USP), 1%, 300 mg/30 mL, single… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5mL (80 mg/mL), 5 mL… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), packaged in:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Bupivacaine HCl Injection, single dose vial, 0.5%, 30 mL/5 mg/mL, Rx only, Manufacturer:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 MethyLPREDNISolone Acetate Injectable Suspension, USP, 200 mg/5 mL (40 mg/mL), 5 mL… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class III June 15, 2022 Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12… Failed Impurities/Degradation Specifications. Novartis Pharmaceuticals Corporation Terminated
Class II June 15, 2022 Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Major Pharma,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 DIPHENHYDRAMINE HYDROCHLORIDE Diphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL unit dose… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 MethyLPREDNISolone Acetate Injectable Suspension, USP, 200mg/5mL (40 mg/mL), 5 mL… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Medroxyprogesterone acetate injectable suspension, 150 mg/mL, 1 mL single dose vial, Rx… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class III June 15, 2022 Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5… Failed Impurities/Degradation Specifications. Novartis Pharmaceuticals Corporation Terminated
Class II June 15, 2022 Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations,… Lack of Assurance of Sterility US Specialty Formulations LLC Terminated
Class II June 15, 2022 GlucaGen (glucagon) for injection, 1 mg per vial, single dose kit, Rx only, Manufactured… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%,… Lack of Assurance of Sterility US Specialty Formulations LLC Terminated
Class II June 15, 2022 Revonto Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 metered… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 prednisolone acetate Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG: Sandoz… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Prazosin Hydrochloride Prazosin Hydrochloride Capsules, USP, 1 mg, 100-count bottle, Rx only, MFG: Mylan Pharma,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Glucagen (glucagon) for injection, packaged in a 10-count box, (10 vials each containing… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Ofloxacin Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmaceuticals,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Epinephrine Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.3 mg, packaged in 2 count… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Aprepitant Aprepitant Capsule, USP, 40 mg, 1 capsule per unit dose package, Rx only, MFG: Sandoz… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Bupivacaine Hydrochloride Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Cefazolin Sodium Cefazolin for injection USP, and Dextrose Injection, USP, 2 g, 50 mL duplex container, Rx… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) transdermal… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, MFG:Sandoz… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Ipratropium Bromide Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25-count box… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Olanzapine Orally Disintegrating Tablets, USP 10 mg, 30-count box unit dose tablets (3… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Epinephrine Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial Diluent… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 EPIPEN EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Dihydroergotamine Mesylate, Injection, USP, 1mg/mL, packaged in box of 5 x 1 mL ampules,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 EPIPEN EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 doxycycline Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Distributed by: Sun… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Mupirocin Mupirocin Ointment, USP 2%, 22 grams tube, Rx only, MFG: Teva Pharma USA, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Cefazolin Sodium Cefazolin for injection USP, and Dextrose Injection, USP, 1G, 50 ML duplex container, Rx… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Ampicillin Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distributed by:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Ondansetron Hydrochloride Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Recothrom Thrombin Topical (Recombinant), 5,000 units, packaged in a box containing a… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Meclizine Hydrochloride Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dose), 10… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only, MFG: Sandoz… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Lidocaine Lidocaine Patch 5%, 30-count box, Rx only, MFG: Teva Pharma USA, NDC 0591-3525-30 cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit dose box, Rx… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Albuterol Sulfate Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3mL unit-dose… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Lidocaine Lidocaine Patch 5%, 30-count carton, Rx only, MFG: Qualitest Products, NDC 0603-1880-16 cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Albuterol Sulfate Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Triamcinolone Acetonide Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sandoz Pharma, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Depo-Medrol Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, packaged in… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Depo-Medrol Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 40 mg/mL, 1 mL… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Adrenalin Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1mg/mL), 30 mL multiple dose vial, Rx… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Albuterol Sulfate Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30… Microbial contamination of non-sterile product. Grato Holdings, Inc. Terminated
Class II June 15, 2022 Amoxicillin Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG: Sandoz… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Diprivan Diprivan (Propofol) Emulsion, 200 mg per 20 mL (10mg/mL), 20 mL vial, Rx only, MFG: App… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Lidocaine and Prilocaine Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes, Rx only, MFG: Sandoz Pharma, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bottle, Rx… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Bupivacaine Hydrochloride Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Ibuprofen Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Ketoconazole Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60 cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Sterile Water Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Geodon for injection (ziprasidone mesylate), 20 mg/mL, 1 mL single dose vial, Rx only,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 E-Z-HD (Barium Sulfate for Oral Suspension), 98% w/w, 340 g bottle, Rx only, MFG: Bracco… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Xylocaine Xylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count box (NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Albuterol Sulfate Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL Sterile… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 BSS BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx only, MFG:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 sumatriptan succinate Sumatriptan Succinate Tablets, 100 mg, 9 (1 x 9) Unit-of- use tablets box, Rx only, MFG:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 hydroxyzine pamoate HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class III June 15, 2022 Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Doxycycline Hyclate Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each blister pack x… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Betamethasone Dipropionate Betamethasone Dipropionate Cream USP, 0.05%, 45 grams tube, Rx only, MFG: Sandoz Pharma,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Diprivan Diprivan (Propofol) Emulsion, 100 mg/mL, 10mL vial, Rx only, MFG: App Pharmaceutical LLC,… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 BSS BSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle, Rx only, MFG:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Xylocaine Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: Bracco… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd.,… Microbial contamination of non-sterile product. Grato Holdings, Inc. Terminated
Class II June 15, 2022 Azithromycin Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Naltrexone Hydrochloride Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG:… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 15, 2022 Levofloxacin Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC… cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II June 8, 2022 AMBI Skincare Fade Cream Oily Skin New & Improved, Net Wt. 2 OZ (56g) cGMP deviations: product stored outside of labeled temperature requirements. Family Dollar Stores, Llc. Ongoing
Class II June 8, 2022 Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer With… cGMP deviations: product stored outside of labeled temperature requirements. Family Dollar Stores, Llc. Ongoing
Class II June 8, 2022 AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment With Oat and… cGMP deviations: product stored outside of labeled temperature requirements. Family Dollar Stores, Llc. Ongoing
Class II June 8, 2022 Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8… cGMP deviations: product stored outside of labeled temperature requirements. Family Dollar Stores, Llc. Ongoing
Class II June 8, 2022 AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g) cGMP deviations: product stored outside of labeled temperature requirements. Family Dollar Stores, Llc. Ongoing
Class II June 8, 2022 Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients, Net… cGMP deviations: product stored outside of labeled temperature requirements. Family Dollar Stores, Llc. Ongoing
Class II June 8, 2022 Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. (236 mL),… cGMP deviations: product stored outside of labeled temperature requirements. Family Dollar Stores, Llc. Ongoing
Class II June 8, 2022 Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%,… Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found… Vi-Jon, LLC Terminated
Class II June 8, 2022 Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe, 5 x… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe, 5… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II June 8, 2022 Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class I June 8, 2022 Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For:… Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing. Teva Pharmaceuticals USA Inc Terminated
Class II June 8, 2022 Losartan Potassium Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Strides Pharma Inc. Terminated
Class II June 8, 2022 Losartan Potassium Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Strides Pharma Inc. Terminated
Class II June 8, 2022 Losartan Potassium Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Strides Pharma Inc. Terminated
Class II June 8, 2022 losartan potassium and hydrochlorothiazide Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Direct Rx Terminated
Class II June 1, 2022 Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Pyridoxine 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 mL vial,… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Zinc Chloride (0.5 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. RemedyRepack Inc. Terminated
Class II June 1, 2022 Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Preferred Pharmaceuticals, Inc. Terminated
Class II June 1, 2022 Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size:… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Preferred Pharmaceuticals, Inc. Terminated
Class II June 1, 2022 Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. RemedyRepack Inc. Terminated
Class III June 1, 2022 Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per… Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the… Eco Lips, Inc Terminated
Class II June 1, 2022 Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC#… CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits RemedyRepack Inc. Terminated
Class I June 1, 2022 Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott… Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a… Calvin Scott & Company, Inc. Terminated
Class III June 1, 2022 Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distributed by Calvin… Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a… Calvin Scott & Company, Inc. Terminated
Class II June 1, 2022 Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Diluent for Reconstitution Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine HCL 100 mg/mL Lysine HCL… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL vial, Rx… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx Only,… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 mg/mL,… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) 2.5 mL… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olympia… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Packaged as a) 5 mL… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi-Dose Vial,… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Ultratest Testosterone Cypionate 160 mg/mL Testosterone Propionate 40 mg/mL, Multi-Dose… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL,… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed
Class II June 1, 2022 Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline… Lack of assurance of sterility. Olympia Compounding Pharmacy dba Olympia Pharmacy Completed