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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 March 23, 2022 Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family… Lack of Assurance of Sterility Family Pharmacy of Statesville Terminated
Class II March 23, 2022 Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of… Lack of Assurance of Sterility Family Pharmacy of Statesville Terminated
Class II March 23, 2022 Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of… Lack of Assurance of Sterility Family Pharmacy of Statesville Terminated
Class II March 23, 2022 Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of… Lack of Assurance of Sterility Family Pharmacy of Statesville Terminated
Class II March 23, 2022 Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab… CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process. Golden State Medical Supply Inc. Terminated
Class II March 23, 2022 Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville,… Lack of Assurance of Sterility Family Pharmacy of Statesville Terminated
Class II March 23, 2022 Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of… Lack of Assurance of Sterility Family Pharmacy of Statesville Terminated
Class II March 23, 2022 Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of… Lack of Assurance of Sterility Family Pharmacy of Statesville Terminated
Class II March 23, 2022 SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical… Lack of sterility assurance: leaking bags B. Braun Medical, Inc. Terminated
Class II March 23, 2022 Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials,… Lack of Assurance of Sterility Family Pharmacy of Statesville Terminated
Class II March 23, 2022 Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville,… Lack of Assurance of Sterility Family Pharmacy of Statesville Terminated
Class II March 23, 2022 Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of… Lack of Assurance of Sterility Family Pharmacy of Statesville Terminated
Class II March 23, 2022 Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. Lack of Assurance of Sterility Family Pharmacy of Statesville Terminated
Class II March 23, 2022 Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx… Lack of Assurance of Sterility Family Pharmacy of Statesville Terminated
Class I March 23, 2022 Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA… Walmart Stores Terminated
Class II March 23, 2022 hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx… Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for… The Harvard Drug Group Terminated
Class II March 16, 2022 Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut… CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab… Direct Rx Terminated
Class II March 16, 2022 Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut… CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab… Direct Rx Terminated
Class II March 16, 2022 Oxycodone Hydrochloride Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1… Impurity failure at 0-time of the repackaged lot. American Health Packaging Terminated
Class II March 16, 2022 Paliperidone PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister… Failed Dissolution Specifications The Harvard Drug Group Terminated
Class II March 9, 2022 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle,… Labeling - product contains undeclared ethyl alcohol Tsm Brands LLC Ongoing
Class II March 9, 2022 Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands… Labeling - product contains undeclared ethyl alcohol Tsm Brands LLC Ongoing
Class II March 9, 2022 All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in… CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Dollar Tree Distribution, Inc. Ongoing
Class II March 9, 2022 HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown… Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the… Vi-Jon, Inc. Terminated
Class II March 9, 2022 Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC:… CGMP deviations Preferred Pharmaceuticals, Inc. Terminated
Class II March 9, 2022 Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx… Failed impurities/degradation specifications Direct Rx Terminated
Class II March 9, 2022 Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only,… Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the… Morton Grove Pharmaceuticals, Inc. Terminated
Class II March 9, 2022 Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only,… cGMP deviations Macleods Pharma Usa Inc Terminated
Class II March 9, 2022 Olanzapine Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods… cGmp Deviations Macleods Pharma Usa Inc Terminated
Class II March 2, 2022 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle,… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v,… cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products. Professional Disposables International, Inc. Terminated
Class II March 2, 2022 Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as… Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol. AMS Packaging Inc Ongoing
Class II March 2, 2022 Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as… Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol. AMS Packaging Inc Ongoing
Class I March 2, 2022 RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA… Positive Health Terminated
Class III March 2, 2022 Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only,… Subpotent drug BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy Terminated
Class II March 2, 2022 Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner… cGMP deviations Pharmasol Corporation Terminated
Class II March 2, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and… cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products. Professional Disposables International, Inc. Terminated
Class II March 2, 2022 Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo pack. DS SR… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL)… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL)… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 No Drip Nasal Decongestant, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle,… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL)… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class III March 2, 2022 Azacitidine Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories… Failed stability specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II March 2, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70%… cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products. Professional Disposables International, Inc. Terminated
Class III March 2, 2022 Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per… Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg. Dr. Reddy's Laboratories, Inc. Terminated
Class II March 2, 2022 No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL)… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Methylphenidate Hydrochloride Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only,… Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market… RISING PHARMACEUTICALS Ongoing
Class II March 2, 2022 Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Severe Congestion No Drip Nasal Spray Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 No Drip Nasal Mist, Oxymetazoline HCl 0.05% Nasal decongestant, 1 FL Oz (30 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL)… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL)… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class III March 2, 2022 Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories… Failed stability specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II March 2, 2022 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% Nasal… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class III March 2, 2022 Azacitidine Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's… Failed stability specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II March 2, 2022 Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL)… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL)… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 FL OZ (118… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II March 2, 2022 Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30… CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Perrigo Company PLC Terminated
Class II February 23, 2022 Chlorthalidone Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio… Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone… SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class I February 23, 2022 THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA… Your Favorite Shop Terminated
Class II February 23, 2022 Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab… cGMP Deviations ANI Pharmaceuticals, Inc. Terminated
Class II February 23, 2022 Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b)… cGMP Deviations ANI Pharmaceuticals, Inc. Terminated
Class I February 23, 2022 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a… Je Dois Lavoir LLC Terminated
Class II February 23, 2022 NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz… MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae. Organics Corporation of America DBA Ambix Laboratories Ongoing
Class II February 23, 2022 Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER,… Failed Impurities/Degradation Specifications: Out of specification results for related substances. Lannett Company, Inc. Terminated
Class I February 23, 2022 HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe,… Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as… STAQ Pharma, Inc. Terminated
Class II February 23, 2022 Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b)… cGMP Deviations ANI Pharmaceuticals, Inc. Terminated
Class II February 23, 2022 Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b)… cGMP Deviations ANI Pharmaceuticals, Inc. Terminated
Class I February 23, 2022 MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC… Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients… ABC Sales 1 Inc Terminated
Class I February 23, 2022 PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an… Non-sterility CooperSurgical, Inc Terminated
Class I February 23, 2022 Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx… Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as… STAQ Pharma, Inc. Terminated
Class II February 23, 2022 Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent… Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds. Teligent Pharma, Inc. Terminated
Class II February 23, 2022 Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b)… cGMP Deviations ANI Pharmaceuticals, Inc. Terminated
Class I February 23, 2022 MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC… Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients… ABC Sales 1 Inc Terminated
Class I February 23, 2022 RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI,… Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients… Celebrate Today Terminated
Class I February 23, 2022 HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV… Non-sterility; bacterial contamination identified as Paenibacillus lautus. Revive Rx LLC dba Revive Rx Pharmacy Terminated
Class II February 23, 2022 MOXIFLOXACIN Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only,… Failed Impurities/Degradation Specifications Aurobindo Pharma USA Inc. Terminated
Class I February 16, 2022 HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton,… Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of… Esupplementsales, LLC Terminated
Class I February 16, 2022 MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a… Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA… Junp Hydration LLC Terminated
Class II February 16, 2022 Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories,… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc.,… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories,… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc.,… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories,… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg)… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg)… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories,… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc.,… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg)… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg,… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland,… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc.,… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class II February 16, 2022 Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container,… CGMP Deviations ULTRAtab Laboratories, Inc. Terminated
Class I February 16, 2022 POLYMYXIN B Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials… Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot AuroMedics Pharma LLC Terminated
Class II February 9, 2022 AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist.… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg )… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc.… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 PEPTIME Energy (caffeine 350mg) tablets, packaged in a) 6 count packets and b) 100-count… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial,… Lack of Assurance of Sterility Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy Ongoing
Class II February 9, 2022 Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a)… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a)… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 PEPTIME Energy (caffeine 250mg) tablets, 100-count bottles, Marketed by: DMD… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325… cGMP deviations Ultra Seal Corporation Terminated
Class III February 9, 2022 Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons… Mislabeling Teva Pharmaceuticals USA Terminated
Class III February 9, 2022 Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in… Mislabeling Teva Pharmaceuticals USA Terminated
Class II February 9, 2022 Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg,… cGMP deviations Ultra Seal Corporation Terminated
Class II February 9, 2022 Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc.,… Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution. Teva Pharmaceuticals USA Terminated
Class II February 9, 2022 Doxylamine Succinate and Pyridoxine Hydrochloride Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg,… Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient Teva Pharmaceuticals USA Terminated
Class II February 9, 2022 Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets)… cGMP deviations Ultra Seal Corporation Terminated
Class II February 2, 2022 Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper,… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose… CGMP Deviations Edge Pharma, LLC Terminated
Class III February 2, 2022 CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium… Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Dental Alliance Holdings LLC Terminated
Class III February 2, 2022 CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2… Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Dental Alliance Holdings LLC Terminated
Class II February 2, 2022 MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial,… CGMP Deviations Edge Pharma, LLC Terminated
Class III February 2, 2022 CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral… Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Dental Alliance Holdings LLC Terminated
Class II February 2, 2022 Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution,… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class III February 2, 2022 CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride… Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Dental Alliance Holdings LLC Terminated
Class II February 2, 2022 Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution,… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 CSF-HC Otic Insufflation Capsule, Sulfacetamide… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution,… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical… CGMP Deviations Edge Pharma, LLC Terminated
Class III February 2, 2022 CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride… Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Dental Alliance Holdings LLC Terminated
Class III February 2, 2022 CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC:… Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Dental Alliance Holdings LLC Terminated
Class III February 2, 2022 CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride… Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Dental Alliance Holdings LLC Terminated
Class II February 2, 2022 Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% /… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl,… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC,… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free,… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV… Lack of Assurance of Sterility Edge Pharma, LLC Terminated
Class II February 2, 2022 Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%,… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection… CGMP Deviations Edge Pharma, LLC Terminated
Class II February 2, 2022 Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag… Lack of Assurance of Sterility Edge Pharma, LLC Terminated