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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 April 15, 2020 LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing… CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Teva Pharmaceuticals USA Ongoing
Class II April 15, 2020 LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing… CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Teva Pharmaceuticals USA Ongoing
Class II April 15, 2020 De-Fibroidin, 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 New Life, 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 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 Max Slim, 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 Reman-AP, 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 MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable,… Lack of Assurance of Sterility Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy Terminated
Class II April 15, 2020 Reman-8, 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 Reman-6, 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 Stop 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 PC Shrinker, 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 25 mg, Bulk, Rx only, For Further Manufacturing, Packing… CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Teva Pharmaceuticals USA Ongoing
Class II April 15, 2020 Asma Stopper, 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 Hernia 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 Blood Clot Purger, 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 Acne 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 Edema 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 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 Skin Moist, 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 Stopper, 500mg Capsules, 90-count bottle, 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 Detoxin Ex, 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 Ex, 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 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 Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC… 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 Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING… Lack of Assurance of Sterility Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy Terminated
Class II April 15, 2020 Asthma Chest Rub, 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 Vigo-XXX, 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 Lift, 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 Thyro-Lo, 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 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 Fire 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 Lupus Care, 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 Pimples Off Solution 60 ML, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081… CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Herbal Doctor Remedies Terminated
Class II April 15, 2020 fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per… Firm is recalling 46 lots of various products because of a lack of sterility assurance. PharMEDium Services, LLC Terminated
Class II April 15, 2020 HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30… Firm is recalling 46 lots of various products because of a lack of sterility assurance. PharMEDium Services, LLC Terminated
Class II April 15, 2020 ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For… Firm is recalling 46 lots of various products because of a lack of sterility assurance. PharMEDium Services, LLC Terminated
Class II April 15, 2020 ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe,… Firm is recalling 46 lots of various products because of a lack of sterility assurance. PharMEDium Services, LLC Terminated
Class II April 15, 2020 fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx… Firm is recalling 46 lots of various products because of a lack of sterility assurance. PharMEDium Services, LLC Terminated
Class II April 15, 2020 fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium… Firm is recalling 46 lots of various products because of a lack of sterility assurance. PharMEDium Services, LLC Terminated
Class II April 15, 2020 succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use,… Firm is recalling 46 lots of various products because of a lack of sterility assurance. PharMEDium Services, LLC Terminated
Class I April 15, 2020 Tetracycline Hydrochloride Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for:… Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules. Avet Pharmaceuticals, Inc. Terminated
Class II April 15, 2020 ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe,… Firm is recalling 46 lots of various products because of a lack of sterility assurance. PharMEDium Services, LLC Terminated
Class II April 15, 2020 nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a… Firm is recalling 46 lots of various products because of a lack of sterility assurance. PharMEDium Services, LLC Terminated
Class II April 15, 2020 ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe,… Firm is recalling 46 lots of various products because of a lack of sterility assurance. PharMEDium Services, LLC Terminated
Class II April 15, 2020 fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use,… Firm is recalling 46 lots of various products because of a lack of sterility assurance. PharMEDium Services, LLC 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 I April 15, 2020 Tetracycline Hydrochloride Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for:… Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules. Avet Pharmaceuticals, Inc. Terminated
Class II April 8, 2020 C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Medical Center Pharmacy, Inc. Terminated
Class II April 8, 2020 Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tamiami Trail… Lack of Assurance of Sterility The Medicine Shoppe Pharmacy Terminated
Class II April 8, 2020 C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Medical Center Pharmacy, Inc. Terminated
Class III April 8, 2020 Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL… Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%)… Akorn Inc Terminated
Class II April 8, 2020 C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy,… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Medical Center Pharmacy, Inc. Terminated
Class I April 8, 2020 Phytonadione Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged… Defective Container: Recall is due to breaking and shattering of ampules upon opening Dr. Reddy's Laboratories, Inc. Terminated
Class II April 8, 2020 Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par… Failed Impurities/Degradation Specification: Presence of unknown impurity observed. Par Pharmaceutical Inc. Terminated
Class II April 8, 2020 *Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Medical Center Pharmacy, Inc. Terminated
Class II April 8, 2020 *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401… Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products… Medical Center Pharmacy, Inc. Terminated
Class I April 8, 2020 Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured… Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved… Y-O Management LLC, dba Natural Remedy Store Terminated
Class II April 8, 2020 Lisinopril Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin… Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside… Lupin Pharmaceuticals Inc. Terminated
Class II April 1, 2020 Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with cardboard… Subpotent Drug Matthew 7:25 Inc dba Thrive Pharmacy Terminated
Class II April 1, 2020 Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC… Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug… Glaxosmithkline Consumer Healthcare Holdings Terminated
Class II April 1, 2020 Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with cardboard… Subpotent Drug Matthew 7:25 Inc dba Thrive Pharmacy Terminated
Class II April 1, 2020 Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard… Subpotent Drug Matthew 7:25 Inc dba Thrive Pharmacy Terminated
Class II April 1, 2020 DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg… Failed Stability Specifications Jubilant Draximage Inc Terminated
Class II April 1, 2020 NYSTATIN Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz… SubPotent Drug: Low out-of-specification results for assay testing. PAI Holdings, LLC. dba Pharmaceutical Associates Inc Terminated
Class II April 1, 2020 Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559… Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug… Glaxosmithkline Consumer Healthcare Holdings Terminated
Class II April 1, 2020 Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape… Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug… Glaxosmithkline Consumer Healthcare Holdings Terminated
Class III April 1, 2020 Tacrolimus Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc.,… Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles. Mylan Pharmaceuticals Inc. Terminated
Class II April 1, 2020 Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only,… CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product… Nostrum Laboratories Inc Terminated
Class II April 1, 2020 Advil Allergy and Congestion Relief Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy… Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug… Glaxosmithkline Consumer Healthcare Holdings Terminated
Class III April 1, 2020 Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by… Labeling mix-up - Indications on product label are incorrect. Grato Holdings, Inc. Terminated
Class II April 1, 2020 Advil Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC… Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug… Glaxosmithkline Consumer Healthcare Holdings Terminated
Class II March 25, 2020 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand]… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle.… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle.… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle.… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle.… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33)… CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. Breckenridge Pharmaceutical, Inc Terminated
Class II March 25, 2020 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle.… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle.… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33)… CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. Breckenridge Pharmaceutical, Inc Terminated
Class II March 25, 2020 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle.… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle.… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals… Presence of particulate matter. presence of metal particles. Mylan Pharmaceuticals Inc. Terminated
Class II March 25, 2020 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle.… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius… CGMP Deviation: Chemical indicators were not positioned properly during sterilization process. Fresenius Medical Care Holdings, Inc. Terminated
Class II March 25, 2020 Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma… Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of… RemedyRepack Inc. Terminated
Class II March 25, 2020 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle.… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class II March 25, 2020 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle.… CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Perrigo Company PLC Terminated
Class I March 25, 2020 UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack,… Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis. Med Man Distribution, Inc. Terminated
Class I March 25, 2020 Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Ten pack… Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis. Med Man Distribution, Inc. Terminated
Class II March 25, 2020 doxycycline Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm… CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions. Sun Pharmaceutical Industries, Inc. Terminated
Class II March 25, 2020 Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only,… CGMP Deviations: Presence of dark brown discoloration on edges of tablets Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class II March 25, 2020 Daytrana Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3… Defective Delivery System: Out of specification for mechanical peel and shear. Noven Therapeutics, LLC Terminated
Class II March 25, 2020 doxycycline Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm… CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions. Sun Pharmaceutical Industries, Inc. Terminated
Class II March 25, 2020 Daytrana Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2… Defective Delivery System: Out of specification for mechanical peel and shear. Noven Therapeutics, LLC Terminated
Class II March 25, 2020 Daytrana Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1… Defective Delivery System: Out of specification for mechanical peel and shear. Noven Therapeutics, LLC Terminated
Class II March 25, 2020 Daytrana Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6… Defective Delivery System: Out of specification for mechanical peel and shear. Noven Therapeutics, LLC Terminated
Class III March 25, 2020 Prednisone PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par… Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5… Par Pharmaceutical Inc. Terminated
Class II March 25, 2020 ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun… Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium… Sun Pharmaceutical Industries, Inc. Terminated
Class III March 25, 2020 Potassium Chloride Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx… Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg. Strides Pharma Science Limited Terminated
Class III March 18, 2020 Quetiapine Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton,… Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate… The Harvard Drug Group Terminated
Class II March 18, 2020 Vancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, 2415 Osborne… Lack Of Processing Controls Redline Pharmacy Solutions Terminated
Class II March 18, 2020 Ertapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 2415 Osborne… Lack Of Processing Controls Redline Pharmacy Solutions Terminated
Class II March 18, 2020 Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy,… Lack Of Processing Controls Redline Pharmacy Solutions Terminated
Class III March 18, 2020 Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl… Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity. Lupin Pharmaceuticals Inc. Terminated
Class II March 18, 2020 Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC:… CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. Precision Dose Inc. Terminated
Class II March 18, 2020 Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty… Lack Of Processing Controls Redline Pharmacy Solutions Terminated
Class II March 18, 2020 Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Specialty… Lack Of Processing Controls Redline Pharmacy Solutions Terminated
Class II March 18, 2020 Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, 2415 Osborne… Lack Of Processing Controls Redline Pharmacy Solutions Terminated
Class II March 18, 2020 Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and… Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity. Lupin Pharmaceuticals Inc. Terminated
Class II March 18, 2020 Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only,… CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. American Health Packaging Terminated
Class II March 18, 2020 Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b)… Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in… H J Harkins Company Inc dba Pharma Pac Terminated
Class II March 18, 2020 Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC… cGMP Deviation Sunstar Guangzhou Ltd. Terminated
Class II March 18, 2020 Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma,… Product Mix-Up: A foreign tablet was found in bottle. Mayne Pharma Inc Terminated
Class III March 18, 2020 Quetiapine Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton,… Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate… The Harvard Drug Group Terminated
Class III March 18, 2020 Quetiapine Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx… Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate… The Harvard Drug Group Terminated
Class III March 18, 2020 Quetiapine Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton,… Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate… The Harvard Drug Group Terminated
Class II March 11, 2020 Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only,… Failed Impurities/Degradation Specification; high out of specification results observed Lupin Pharmaceuticals Inc. Terminated
Class II March 11, 2020 BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM,… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For IV, IM, SC… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 mL Multi-dose… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Calcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial,… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Coenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL Multi-dose… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use,… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Multi-dose Vial,… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML]… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE (PF) CMC… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM, SC Use, 30… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 30 mL… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF)… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Hydroxocobalamin Injection, HYDROXOCOBALAMIN 5MG/ML INJECTABLE, For IV, IM Use,… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use,… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class III March 11, 2020 Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use, 50 mL… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE, For IM Use, Refrigerate.… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML:… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML]… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Deoxycholic Acid Sodium Injection,DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE, For SC Use,… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE, For IM… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML]… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 MIC-PLEX Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class III March 11, 2020 Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg… Labeling: Incorrect or Missing Lot and/or Expiration date. AAA Pharmaceutical, Inc. Terminated
Class II March 11, 2020 Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Shake Well, 30… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF)… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use,… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV, IM, SC Use,… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM,… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Glycerin (PF) Injection,GLYCERIN 99% INJECTABLE, For IV Use,10 mL Single-use Vial, Rx… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone… Lack of Assurance of Sterility Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical Terminated
Class II March 11, 2020 Mesalamine Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only,… Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing. Teva Pharmaceuticals USA Terminated
Class II March 11, 2020 Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by… Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either… Pfizer Inc. Terminated
Class III March 4, 2020 Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc.,… Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace… Akorn, Inc. Terminated
Class III March 4, 2020 CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS… Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace… Akorn, Inc. Terminated
Class III March 4, 2020 Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed… Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace… Akorn, Inc. Terminated
Class III March 4, 2020 Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion,… Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability… Breckenridge Pharmaceutical, Inc Terminated
Class I March 4, 2020 Phenytoin Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by:… Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per… Taro Pharmaceuticals U.S.A., Inc. Terminated
Class III March 4, 2020 TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC… Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language… Golden State Medical Supply Inc. Terminated
Class II February 26, 2020 Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE… Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity. NCS Healthcare of Kentucky Inc Terminated
Class III February 26, 2020 Glycopyrrolate Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx… Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative… AuroMedics Pharma LLC Terminated
Class II February 26, 2020 Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx… GMP Deviations: Product bottle may be absent of desiccant. American Health Packaging Terminated
Class II February 26, 2020 Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx… GMP Deviations: Product bottle may be absent of desiccant. American Health Packaging Terminated
Class III February 26, 2020 memantine hydrochloride Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose… Failed Dissolution Specifications: High out of specification result observed at stability studies. The Harvard Drug Group Terminated
Class III February 26, 2020 Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC… Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language… Teva Pharmaceuticals USA Terminated
Class I February 19, 2020 Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by:… Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black… RemedyRepack Inc. Terminated
Class II February 19, 2020 New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient… Microbial Contamination of Non-Sterile Products Efficient Laboratories, Inc. Terminated
Class II February 19, 2020 Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient… Microbial Contamination of Non-Sterile Products Efficient Laboratories, Inc. Terminated
Class II February 19, 2020 Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient… Microbial Contamination of Non-Sterile Products Efficient Laboratories, Inc. Terminated
Class II February 19, 2020 Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each… Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in… Pfizer Inc. Terminated
Class II February 19, 2020 Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton.… Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a… GSK Consumer Health, Inc Terminated
Class II February 19, 2020 Kushim Tablets (Gushim) 45-count packages, Label in foreign language Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine B AND A TRADING CORPORATION Terminated
Class II February 19, 2020 Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH… Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product. Akorn Inc Terminated
Class II February 19, 2020 Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count… Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in… Contract Pharmacal Corporation Terminated
Class II February 19, 2020 Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged… Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in… Contract Pharmacal Corporation Terminated
Class II February 19, 2020 Raloxifene Hydrochloride Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only,… Failed Dissolution Specifications: Low out of specification results obtained during stability testing. American Health Packaging Terminated
Class III February 19, 2020 Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per… Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022… Par Pharmaceutical Inc. Terminated
Class II February 19, 2020 Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured… cGMP Deviations Zydus Pharmaceuticals USA Inc Terminated
Class II February 19, 2020 memantine hydrochloride Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only,… Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term… Lupin Pharmaceuticals Inc. Terminated
Class II February 19, 2020 Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles,… Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie AuroMedics Pharma LLC Terminated
Class II February 19, 2020 Caduet Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle,… Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could… Pfizer Inc. Terminated
Class II February 19, 2020 Caduet Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle,… Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could… Pfizer Inc. Terminated
Class II February 19, 2020 Methylphenidate Hydrochloride Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle,… CGMP deviations: Product bottle may be absent of desiccant. Teva Pharmaceuticals USA Terminated
Class II February 19, 2020 Methylphenidate Hydrochloride Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle,… CGMP deviations: Product bottle may be absent of desiccant. Teva Pharmaceuticals USA Terminated
Class I February 19, 2020 Lamotrigine Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical… Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II February 12, 2020 Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis… GMP Deviations: Product bottle may be absent of desiccant. Teva Pharmaceuticals USA Terminated
Class II February 12, 2020 Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis… GMP Deviations: Product bottle may be absent of desiccant. Teva Pharmaceuticals USA Terminated
Class II February 12, 2020 Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram,… CGMP Deviations: Presence of NDMA impurity detected in product. Spectrum Laboratory Products Terminated
Class II February 12, 2020 ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b)… CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established… PD-Rx Pharmaceuticals, Inc. Terminated
Class II February 12, 2020 Olmesartan Medoxomil Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by:… cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and… Ascend Laboratories LLC Terminated
Class II February 12, 2020 Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for:… Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a… Graviti Pharmaceuticals Private Limited Terminated
Class III February 12, 2020 Minocycline Hydrochloride Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx… Failed Dissolution Specifications: low out of specification results for dissolution testing. Ascend Laboratories LLC Terminated
Class III February 12, 2020 Clonidine Hydrochloride Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by:… Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential… UNICHEM PHARMACEUTICALS USA INC Terminated
Class III February 12, 2020 Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count… Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin… Macleods Pharma Usa Inc Terminated
Class II February 5, 2020 Magic Bullet Supplement Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 Squaric Acid 0.1% Topical Solution (Clinic) 30 mL Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 NYSTATIN Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz… Subpotent: Out of specification for assay at the 12-month time point. Pharmaceutical Associates Inc Terminated
Class II February 5, 2020 Liothyronine (T3) 80 mcg SR cap Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 DHEA/Pregnenol One 10.25 MG Cap Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 Sildenafil 80 mg capsules Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per… Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing). Shandex Personal Care Manufacturing Inc. Terminated
Class II February 5, 2020 Progesterone 200 mg Troche Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 Tadalafil 20 mg Troche Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 Finasteride/Biotin 1 mg/50 mcg Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 Sildenafil 200 mg Troche (Clinic) Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 Progesterone 50 mg capsules Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 T3/T4 SR 9 mcg/38 mcg capsule Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 Tadalafil 6 mg Capsule Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 Naltrexone 4.5 mg capsule Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated
Class II February 5, 2020 Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV,… Presence of Particulate Matter: Particulates observed in vials release for dispensing. McGuff Compounding Pharmacy Services, Inc. Terminated
Class II February 5, 2020 Progesterone E4M SR 100 mg capsules Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. MPRX, Inc. dba Medical Park Pharmacy Terminated