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

Drug recalls

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

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II September 29, 2021 Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured… CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial… Morton Grove Pharmaceuticals, Inc. Completed
Class II September 29, 2021 Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint… CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial… Morton Grove Pharmaceuticals, Inc. Completed
Class II September 29, 2021 Zonisamide Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc.,… CGMP Deviations Glenmark Pharmaceuticals Inc., USA Terminated
Class II September 29, 2021 Entacapone Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed… Failed Dissolution Specifications The Harvard Drug Group Terminated
Class II September 29, 2021 Zonisamide Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by:… CGMP Deviations Glenmark Pharmaceuticals Inc., USA Terminated
Class III September 29, 2021 Sirolimus Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged… Failed Impurities/Degradation Specifications American Health Packaging Terminated
Class II September 29, 2021 Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets… CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit Pfizer Inc. Ongoing
Class II September 29, 2021 Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count… Subpotent Drug AVRIO HEALTH L.P Terminated
Class II September 29, 2021 CHANTIX Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs,… CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit Pfizer Inc. Ongoing
Class II September 29, 2021 Fulvestrant Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2… Lack of Assurance of Sterility Glenmark Pharmaceuticals Inc., USA Terminated
Class III September 29, 2021 Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC… Subpotency: one product for active ingredient assay and another one for preservative assay Monarch PCM, LLC Terminated
Class II September 29, 2021 Naproxen Sodium Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by:… CGMP Deviations Glenmark Pharmaceuticals Inc., USA Terminated
Class II September 29, 2021 Carbamazepine Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only,… Failed Dissolution Specifications The Harvard Drug Group Terminated
Class II September 29, 2021 Naproxen Sodium Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals… CGMP Deviations Glenmark Pharmaceuticals Inc., USA Terminated
Class I September 22, 2021 Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10… Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine Ebay Seller - John Nguyen Terminated
Class II September 22, 2021 Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle… Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product. Akorn, Inc. Terminated
Class I September 22, 2021 Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only,… Superpotent Drug Teligent Pharma, Inc. Ongoing
Class II September 22, 2021 MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1… Lack of processing controls Promise Pharmacy, LLC Terminated
Class I September 22, 2021 Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz… Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol… Grupo Asimex de Mexico SA de CV Terminated
Class III September 22, 2021 Candesartan cilexetil Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan… Failed Impurities/Degradation Specifications; out of specification for Related Compound Viatris Terminated
Class I September 22, 2021 AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx… Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with… ICU Medical Inc Terminated
Class II September 22, 2021 Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark… Lack of Assurance of Sterility Prescription Labs Inc dba Greenpark Terminated
Class II September 22, 2021 Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz… CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the… Grupo Asimex de Mexico SA de CV Terminated
Class III September 22, 2021 Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for… Failed Impurities/Degradation Specifications Meitheal Pharmaceuticals Inc Terminated
Class II September 22, 2021 Oxycodone Hydrochloride Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by:… Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one… Rhodes Pharmaceuticals, L.P. Terminated
Class II September 22, 2021 Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist. By The… Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary… Vi-Jon, Inc. Terminated
Class II September 15, 2021 HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer… CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above… Charles Paint Research Inc Terminated
Class II September 15, 2021 QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured… Subpotent NATIVE PROMOTIONS, INC Terminated
Class II September 15, 2021 HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer… CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits. Charles Paint Research Inc Terminated
Class II September 8, 2021 Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only,… CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and… Teva Pharmaceuticals USA Terminated
Class I September 8, 2021 MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL… Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl… Global Sanitizers LLC Ongoing
Class II September 8, 2021 Clopidogrel Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods… Presence of foreign matter Macleods Pharma Usa Inc Terminated
Class III September 8, 2021 Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant… Subpotent Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class II September 8, 2021 MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl… CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same… Global Sanitizers LLC Ongoing
Class II September 8, 2021 MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5… CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same… Global Sanitizers LLC Ongoing
Class II September 8, 2021 MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5… CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same… Global Sanitizers LLC Ongoing
Class II September 8, 2021 MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70%… CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same… Global Sanitizers LLC Ongoing
Class I September 8, 2021 MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5… Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl… Global Sanitizers LLC Ongoing
Class II September 8, 2021 Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube,… Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The… Akorn, Inc. Terminated
Class II September 8, 2021 Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited,… CGMP Deviations Granules USA, Inc. Terminated
Class III September 8, 2021 Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube,… Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine… Teligent Pharma, Inc. Terminated
Class II September 8, 2021 Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only,… CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and… Teva Pharmaceuticals USA Terminated
Class II September 8, 2021 Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only,… CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and… Teva Pharmaceuticals USA Terminated
Class II September 8, 2021 aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a)… CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was… China Gel Inc Ongoing
Class II September 8, 2021 CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2… CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was… China Gel Inc Ongoing
Class II September 8, 2021 CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ… CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was… China Gel Inc Ongoing
Class I September 1, 2021 Atovaquone Oral Suspension Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech,… Temperature abuse: the firm received customer complaints of unusual grittiness in the product. KVK-Tech, Inc. Terminated
Class II September 1, 2021 Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His… Marketed without ANDA/NDA approval HIS ENTERPRISE INC Ongoing
Class II September 1, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II September 1, 2021 PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable… SubPotent: Out of Specification Professional Disposables International, Inc Terminated
Class III September 1, 2021 BLEOMYCIN Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only,… Labeling: Not elsewhere classified: Mislabeling Hikma Pharmaceuticals USA Inc. Terminated
Class I September 1, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000… Non-Sterility: firm's third party lab confirmed microbial contamination. SterRx, LLC Terminated
Class II September 1, 2021 PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional… SubPotent: Out of Specification Professional Disposables International, Inc Terminated
Class II September 1, 2021 Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz)… Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as… ANHUI WELCOME FOREIGN TRADE CO.,LTD. Terminated
Class II September 1, 2021 PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a)… SubPotent: Out of Specification Professional Disposables International, Inc Terminated
Class II September 1, 2021 Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena,… Defective container: possibility for lack of seal integrity. Teligent Pharma, Inc. Ongoing
Class II September 1, 2021 FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd… Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in… Custopharm, Inc. Terminated
Class II September 1, 2021 Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ… A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180… RemedyRepack Inc. Terminated
Class II September 1, 2021 Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous… Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all… XELLIA PHARMACEUTICALS USA, LLC Terminated
Class II September 1, 2021 Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For… Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all… XELLIA PHARMACEUTICALS USA, LLC Terminated
Class II September 1, 2021 PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International,… SubPotent: Out of Specification Professional Disposables International, Inc Terminated
Class II September 1, 2021 Trulicity Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly… Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg /… Eli Lilly & Company Terminated
Class II September 1, 2021 Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC… Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing. SigmaPharm Laboratories LLC Terminated
Class II September 1, 2021 PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional… SubPotent: Out of Specification Professional Disposables International, Inc Terminated
Class II September 1, 2021 PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International,… SubPotent: Out of Specification Professional Disposables International, Inc Terminated
Class II September 1, 2021 PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International,… SubPotent: Out of Specification Professional Disposables International, Inc Terminated
Class II August 25, 2021 Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle,… cGMP deviations: Discolored acetaminophen Spirit Pharmaceuticals Terminated
Class II August 25, 2021 Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle,… Marketed Without an Approved NDA/ANDA High Performance Formulas, L.L.C. (HPF, L.L.C.) Terminated
Class III August 25, 2021 Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF,… Out of specification results for conductivity. DuPont Nutrition USA, Inc Terminated
Class II August 25, 2021 Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only,… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only,… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA,… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only,… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only,… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc.… Correct Labeled Product Mispack Teligent Pharma, Inc. Terminated
Class II August 25, 2021 Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena,… Correct Labeled Product Mispack Teligent Pharma, Inc. Terminated
Class II August 25, 2021 metoclopramide Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva… Lack of Assurance of Sterility Teva Pharmaceuticals USA Terminated
Class II August 25, 2021 Carvedilol Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila… Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle Zydus Pharmaceuticals (USA) Inc Terminated
Class II August 25, 2021 GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack… Failed Stability Specification; Out of specification for Osmolarity Novel Laboratories, Inc. d.b.a LUPIN Terminated
Class II August 25, 2021 CombiPatch (estradiol/norethindrone acetate transdermal system) Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day… Failed Stability Specifications; out of specification for shear. Noven Pharmaceuticals Inc Ongoing
Class II August 25, 2021 CombiPatch (estradiol/norethindrone acetate transdermal system) Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day,… Failed Stability Specifications; out of specification for shear. Noven Pharmaceuticals Inc Ongoing
Class II August 25, 2021 Tizanidine Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's… Failed Tablet/Capsule Specification: Some tablets are shaved Dr. Reddy's Laboratories, Inc. Terminated
Class I August 18, 2021 HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only,… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only,… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a)… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx… Non-Sterility Med Shop Total Care Inc. Terminated
Class I August 18, 2021 C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx… Non-Sterility People's Custom Rx and Clinical Care, LLC Terminated
Class II August 18, 2021 Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis,… Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets,… SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II August 18, 2021 Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY,… Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. PAI Holdings, LLC. dba Pharmaceutical Associates Inc Terminated
Class II August 18, 2021 Ethosuximide Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical… Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. PAI Holdings, LLC. dba Pharmaceutical Associates Inc Terminated
Class II August 18, 2021 Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only,… cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product. Eli Lilly & Company Terminated
Class II August 18, 2021 Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets,… Presence of Foreign Substance- Potential of metal contamination. Aurobindo Pharma USA Inc. Terminated
Class II August 18, 2021 NYSTATIN Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY,… Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. PAI Holdings, LLC. dba Pharmaceutical Associates Inc Terminated
Class II August 11, 2021 Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only,… Lack of sterility assurance BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy Terminated
Class I August 11, 2021 Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea… Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine. Qikmoov LLC Ongoing
Class II August 11, 2021 Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical… CGMP Deviations: Does not meet monograph for denaturant. Cascade Kelly Holdings LLC Terminated
Class II August 11, 2021 Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical… CGMP Deviations: Does not meet monograph for denaturant. Cascade Kelly Holdings LLC Terminated
Class II August 11, 2021 CHANTIX Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs,… CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit Pfizer Inc. Ongoing
Class II August 11, 2021 CHANTIX Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs,… CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit Pfizer Inc. Ongoing
Class II August 11, 2021 CHANTIX Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3… CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit Pfizer Inc. Ongoing
Class II August 4, 2021 Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd… cGMP Deviations API Solutions Inc. Terminated
Class II August 4, 2021 Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama… cGMP Deviations API Solutions Inc. Terminated
Class I July 28, 2021 Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC… Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil… Ummzy, LLC Terminated
Class I July 28, 2021 Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA,… Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil… Ummzy, LLC Terminated
Class I July 28, 2021 Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL. OZ. (100… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri… Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA… Nuri Trading LLC Ongoing
Class I July 28, 2021 Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box,… Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug… Nuri Trading LLC Ongoing
Class I July 28, 2021 Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. OZ. (100… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 Ulta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray, Net Wt.… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 Goose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38 FL. OZ.… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 Goose Creek Hand Sanitizer aloe Optimistic Vibes, Anti-Bacterial Spray, 3.38 FL. OZ. (100… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.38 FL. OZ.… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL. OZ. (100… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 SS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.38 FL. OZ.… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box,… Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and… Nuri Trading LLC Ongoing
Class II July 28, 2021 Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx… Lack of Assurance of Sterility Innoveix Pharmaceuticals Inc Completed
Class I July 28, 2021 Coconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4 FL. OZ.… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class III July 28, 2021 Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated… Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric… LNK International, Inc. Terminated
Class I July 28, 2021 69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA… Nuri Trading LLC Ongoing
Class I July 28, 2021 SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution,… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes,… Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil… Ummzy, LLC Terminated
Class I July 28, 2021 SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 FL. OZ. (100… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class II July 28, 2021 Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular… Lack of Assurance of Sterility Innoveix Pharmaceuticals Inc Completed
Class I July 28, 2021 Goose Creek Hand Sanitizer aloe Champagne Bubbles, Anti-Bacterial Spray, 3.38 FL. OZ.… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 Goose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL. OZ. (100… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 Goose Creek Hand Sanitizer aloe Grape Soda, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL),… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 Goose Creek Hand Sanitizer aloe Tropical Daydream, Anti-Bacterial Spray, 3.38 FL. OZ.… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class I July 28, 2021 SS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical… Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. Scentsational Soaps & Candles Inc Terminated
Class III July 28, 2021 Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC… Failed Impurities/Degradation Specifications Teligent Pharma, Inc. Terminated
Class III July 28, 2021 Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ… Failed Impurities/Degradation Specifications Teligent Pharma, Inc. Terminated
Class I July 21, 2021 Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%,… Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be… Sanit Technologies, LLC dba Durisan Terminated
Class II July 21, 2021 Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or… CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as… Sanit Technologies, LLC dba Durisan Terminated
Class I July 21, 2021 Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or… Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be… Sanit Technologies, LLC dba Durisan Terminated
Class II July 21, 2021 Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%,… CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as… Sanit Technologies, LLC dba Durisan Terminated
Class I July 21, 2021 Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made… Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them… Yamtun7 Terminated
Class I July 21, 2021 Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer, packaged… Hand sanitizer packaged in bottles that resemble beverage containers. Prairie Wolf Spirits Terminated
Class I July 21, 2021 Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in… Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles. Ardil Comercial S.R.L. Ongoing
Class III July 21, 2021 LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per… FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month… Partner Therapeutics Inc Terminated
Class II July 21, 2021 Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla… CGMP Deviations CIPLA Terminated
Class II July 21, 2021 Nifedipine NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose… Failed Dissolution Specification: Out of specification for dissolution during routine stability testing. The Harvard Drug Group Terminated
Class III July 21, 2021 B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutritional,… Superpotent Grato Holdings, Inc. Terminated
Class I July 14, 2021 Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc.… Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned… Teva Pharmaceuticals USA Terminated
Class II July 14, 2021 Xolair Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For… Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12… Genentech Inc Terminated
Class II July 14, 2021 Buprenorphine and Naloxone Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1… Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) Alvogen, Inc Terminated
Class II July 14, 2021 Xylocaine Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP),… Low out of specification results for epinephrine assay. Fresenius Kabi USA LLC Terminated
Class II July 7, 2021 ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar… CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same… DIBAR NUTRICIONAL S DE RL DE CV Terminated
Class I July 7, 2021 DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by… Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol… DIBAR NUTRICIONAL S DE RL DE CV Terminated
Class II July 7, 2021 ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b)… CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same… DIBAR NUTRICIONAL S DE RL DE CV Terminated
Class II July 7, 2021 QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured… Subpotent HOYU(US) LOGISTICS INC Ongoing
Class I July 7, 2021 Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co,… Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil NSNY Distributor Inc Ongoing
Class I July 7, 2021 Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA… Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil NSNY Distributor Inc Ongoing
Class II July 7, 2021 DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.1 mL)… CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same… DIBAR NUTRICIONAL S DE RL DE CV Terminated
Class II June 30, 2021 Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b)… Presence of Foreign Substance: Foreign particles observed during routine stability testing. Teligent Pharma, Inc. Terminated
Class I June 30, 2021 maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed… Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. Miracle 8989 Terminated
Class III June 30, 2021 Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside… Failed Impurities/Degradation Specifications Bausch Health Companies, Inc. Terminated
Class I June 30, 2021 PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in… Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. Miracle 8989 Terminated
Class I June 30, 2021 PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7… Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. Miracle 8989 Terminated
Class III June 30, 2021 Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for:… Failed Impurities/Degradation Specifications Bausch Health Companies, Inc. Terminated
Class II June 30, 2021 DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only,… Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper. Hill Dermaceuticals, Inc. Terminated
Class II June 30, 2021 Metformin Hydrochloride Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only,… CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. VIONA PHARMACEUTICALS INC Terminated
Class III June 23, 2021 Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma… Labeling: Incorrect Exp. Date: Incorrect BUD. Prisma Health Outsourcing Facility Terminated
Class II June 23, 2021 Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty… Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine… DASH XCLUSIVE Ongoing
Class III June 23, 2021 Atorvastatin Calcium Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By:… Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities Dr. Reddy's Laboratories, Inc. Terminated
Class II June 23, 2021 QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui… Subpotent World Source Llc Terminated
Class III June 23, 2021 Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE… Failed Impurities Specification: Out of specification when measuring the impurity degradant D level. AVKARE Inc. Terminated
Class III June 16, 2021 DELFLEX DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and… Temperature Abuse: Product exposed to temperature outside specified limits. Fresenius Medical Care Holdings, Inc. Terminated
Class III June 16, 2021 DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only,… Temperature Abuse: Product exposed to temperature outside specified limits. Fresenius Medical Care Holdings, Inc. Terminated
Class III June 16, 2021 DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium,… Temperature Abuse: Product exposed to temperature outside specified limits. Fresenius Medical Care Holdings, Inc. Terminated
Class II June 16, 2021 Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America,… Temperature Abuse: Product exposed to temperature outside specified limits. Fresenius Medical Care Holdings, Inc. Terminated
Class III June 16, 2021 READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable… Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate. Medline Industries Inc Terminated
Class III June 16, 2021 Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By:… Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen… McKesson Corporation dba McKesson Drug Company Terminated
Class III June 16, 2021 DELFLEX DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and… Temperature Abuse: Product exposed to temperature outside specified limits. Fresenius Medical Care Holdings, Inc. Terminated
Class III June 16, 2021 DELFLEX DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium,… Temperature Abuse: Product exposed to temperature outside specified limits. Fresenius Medical Care Holdings, Inc. Terminated
Class III June 16, 2021 DELFLEX DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium,… Temperature Abuse: Product exposed to temperature outside specified limits. Fresenius Medical Care Holdings, Inc. Terminated
Class III June 16, 2021 DELFLEX DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and… Temperature Abuse: Product exposed to temperature outside specified limits. Fresenius Medical Care Holdings, Inc. Terminated
Class III June 9, 2021 Thiamine Hydrochloride Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL… Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled… Mylan Institutional LLC Terminated
Class II June 9, 2021 Buspirone Hydrochloride BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By:… Presence of Foreign Tablets/Capsules Oxford Pharmaceuticals, LLC Completed
Class I June 9, 2021 Bupivacaine Hydrochloride 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose… Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1%… PFIZER, INC Terminated
Class II June 9, 2021 Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC… Subpotent Drug Boehringer Ingelheim Pharmaceuticals, Inc. Terminated
Class I June 9, 2021 Lidocaine Hydrochloride 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC… Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1%… PFIZER, INC Terminated
Class II June 2, 2021 OZEMPIC Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 CHANTIX Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 BELBUCA Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Cyanocobalamin CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIAL CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class III June 2, 2021 Atorvastatin Calcium Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's… Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities Dr. Reddy's Laboratories, Inc. Terminated
Class II June 2, 2021 OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX;… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by:… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Prilosec Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by:… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Levofloxacin Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Epinephrine EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS)… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Pantoprazole Sodium Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 PHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULES CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew,… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 HYDROCORTISONE 1% 30gm cream CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by:… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX;… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated
Class II June 2, 2021 Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon… CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. Terminated