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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 III September 5, 2018 Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx… Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide Akorn, Inc. Terminated
Class II September 5, 2018 Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL… Lack of assurance of sterility. Pharmcore Inc. Terminated
Class II September 5, 2018 Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Torrent Pharma Inc. Ongoing
Class II September 5, 2018 Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs… Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be… Auro Pharmacies, Inc. Terminated
Class II September 5, 2018 Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd.… Lack of assurance of sterility. Pharmcore Inc. Terminated
Class II September 5, 2018 Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd.… Lack of assurance of sterility. Pharmcore Inc. Terminated
Class II September 5, 2018 Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. AVKARE Inc. Terminated
Class II September 5, 2018 CHILDRENS ADVIL Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml)… Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the… Pfizer Global Supply Terminated
Class I September 5, 2018 Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Living Well… Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification… Living Well Remedies, LLC Terminated
Class III September 5, 2018 Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by:… Subpotency: lower than expected potency result was obtained at the 18 month stability time point. Validus Pharmaceuticals, Inc. Terminated
Class III September 5, 2018 Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy… Subpotency: lower than expected potency result was obtained at the 18 month stability time point. Validus Pharmaceuticals, Inc. Terminated
Class II September 5, 2018 SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation… CGMP Deviations Baxter Healthcare Corporation Terminated
Class II September 5, 2018 Doxycycline Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02;… Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed… PD-Rx Pharmaceuticals, Inc. Terminated
Class I August 29, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg), 100-count… Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical… Westminster Pharmaceuticals LLC Terminated
Class I August 29, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count… Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical… Westminster Pharmaceuticals LLC Terminated
Class II August 29, 2018 Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. A-S Medication Solutions LLC. Ongoing
Class II August 29, 2018 Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. A-S Medication Solutions LLC. Ongoing
Class III August 29, 2018 Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10… Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Terminated
Class I August 29, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100-count… Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical… Westminster Pharmaceuticals LLC Terminated
Class II August 29, 2018 Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. A-S Medication Solutions LLC. Ongoing
Class II August 29, 2018 Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Preferred Pharmaceuticals, Inc Terminated
Class I August 29, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count… Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical… Westminster Pharmaceuticals LLC Terminated
Class I August 29, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count… Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical… Westminster Pharmaceuticals LLC Terminated
Class II August 29, 2018 Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. A-S Medication Solutions LLC. Ongoing
Class II August 29, 2018 Valsartan Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Hetero Labs Limited Unit V Completed
Class II August 29, 2018 Valsartan Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Hetero Labs Limited Unit V Completed
Class II August 29, 2018 Valsartan Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Hetero Labs Limited Unit V Completed
Class II August 29, 2018 Valsartan Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Hetero Labs Limited Unit V Completed
Class III August 29, 2018 Valsartan Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant… Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class III August 29, 2018 Valsartan Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant… Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class III August 29, 2018 Valsartan Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant… Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class III August 29, 2018 Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant… Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class II August 22, 2018 Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. RemedyRepack Inc. Terminated
Class II August 22, 2018 Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. RemedyRepack Inc. Terminated
Class II August 22, 2018 alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube.… Microbial Contamination of a Non-Sterile Product The Hain Celestial Group, Inc. - Worldwide HQ Terminated
Class III August 22, 2018 Atorvastatin Calcium Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's… Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation… Dr. Reddy's Laboratories, Inc. Terminated
Class II August 22, 2018 Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. RemedyRepack Inc. Terminated
Class II August 22, 2018 Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1107 Lowry… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial,… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Northwind Pharmaceuticals LLC Terminated
Class II August 22, 2018 Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL,… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial,… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laboratory, 1107… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL,… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection,… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx… Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be… Ranier's Compounding Laboratory Terminated
Class II August 22, 2018 Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Northwind Pharmaceuticals LLC Terminated
Class II August 22, 2018 Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Northwind Pharmaceuticals LLC Terminated
Class II August 22, 2018 Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Northwind Pharmaceuticals LLC Terminated
Class III August 22, 2018 Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by:… Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label. Huijing (Shanghai) Bio-tech Co., Ltd. Terminated
Class II August 22, 2018 Lisinopril Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin… Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet. Lupin Pharmaceuticals Inc. Terminated
Class III August 22, 2018 Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg,… Defective Container: Customer complaints of punctures in the bottle. Orexigen Therapeutics, Inc. Terminated
Class II August 15, 2018 Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL… CGMP deviations: Product was released while a hood certification discrepancy was being investigated. PharMEDium Services, LLC Terminated
Class II August 15, 2018 Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC… CGMP Deviations Longbow First Aid Products Manufactory Terminated
Class II August 15, 2018 Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. NuCare Pharmaceuticals Inc Terminated
Class II August 15, 2018 Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian Pharmacy… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. Compounded… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class III August 15, 2018 Diazepam Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal… Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the… Valeant Pharmaceuticals North America LLC Terminated
Class II August 15, 2018 Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured… API material used in the manufacturing of the product did not receive regulatory approval prior to release. Teva Pharmaceuticals USA Terminated
Class II August 15, 2018 10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC. CGMP deviations: Product was released while a hood certification discrepancy was being investigated. PharMEDium Services, LLC Terminated
Class II August 15, 2018 Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class III August 15, 2018 Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy.,… Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label Right Value Drug Stores, Inc. Terminated
Class II August 15, 2018 Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. NuCare Pharmaceuticals Inc Terminated
Class II August 15, 2018 Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate.… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounded Guardian… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. NuCare Pharmaceuticals Inc Terminated
Class II August 15, 2018 B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC… CGMP Deviations Longbow First Aid Products Manufactory Terminated
Class II August 15, 2018 Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx… Defective Container: Tamper Evident foil seal not completely intact. Morton Grove Pharmaceuticals, Inc. Terminated
Class II August 15, 2018 Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class II August 15, 2018 5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD… CGMP deviations: Product was released while a hood certification discrepancy was being investigated. PharMEDium Services, LLC Terminated
Class II August 15, 2018 Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian… Lack of sterility assurance. Guardian Pharmacy Services Terminated
Class I August 15, 2018 Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White… Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the… World Organix, LLC Terminated
Class II August 15, 2018 Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech… Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during… Akorn, Inc. Terminated
Class I August 15, 2018 Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While… Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the… World Organix, LLC Terminated
Class I August 15, 2018 Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed… Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the… World Organix, LLC Terminated
Class I August 15, 2018 Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml)… Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the… World Organix, LLC Terminated
Class I August 15, 2018 Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil… Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the… World Organix, LLC Terminated
Class II August 15, 2018 Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50… Presence of foreign substance: Potential for glass in the neck area of the glass bottles. Mylan Pharmaceuticals Inc. Terminated
Class II August 15, 2018 Kit for the Preparation of Technetium Tc 99M Medronate Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a)… Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility. Pharmalucence, Inc. Terminated
Class III August 15, 2018 Levofloxacin Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50… Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. Baxter Healthcare Corporation Terminated
Class III August 15, 2018 Levofloxacin Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose,… Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. Baxter Healthcare Corporation Terminated
Class III August 15, 2018 Levofloxacin Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose,… Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. Baxter Healthcare Corporation Terminated
Class II August 8, 2018 Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx… Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion… PFIZER Terminated
Class II August 8, 2018 Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Bryant Ranch Prepack Inc. Terminated
Class III August 8, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2… Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay. Renaissance Lakewood, LLC Terminated
Class III August 8, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2… Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and… Renaissance Lakewood, LLC Terminated
Class II August 8, 2018 Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles (… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Bryant Ranch Prepack Inc. Terminated
Class II August 8, 2018 Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc.… Carcinogen impurity detected in API used to manufacture drug product. H J Harkins Company Inc dba Pharma Pac Terminated
Class III August 8, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2… Failed Stability Specifications: lot out of specification for elevated water vapor. Renaissance Lakewood, LLC Terminated
Class II August 8, 2018 Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. RemedyRepack Inc. Terminated
Class II August 8, 2018 Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. RemedyRepack Inc. Terminated
Class II August 8, 2018 Valsartan Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Bryant Ranch Prepack Inc. Terminated
Class II August 8, 2018 Indomethacin Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber… Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together… Hetero Labs, Ltd. - Unit III Terminated
Class II August 8, 2018 Doxycycline Hyclate Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by:… Failed Dissolution Specifications: West-Ward Columbus Inc Terminated
Class III August 8, 2018 MOXIFLOXACIN Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin… Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three… Lupin Pharmaceuticals Inc. Terminated
Class II August 8, 2018 Doxycycline Hyclate Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by:… Failed Dissolution Specifications: West-Ward Columbus Inc Terminated
Class II August 8, 2018 POTASSIUM CITRATE Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only,… Failed Tablet/Capsule Specifications: Tablet breakage VENSUN PHARMACEUTICALS INC Terminated
Class II August 8, 2018 POTASSIUM CITRATE Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only,… Failed Tablet/Capsule Specifications: Tablet breakage VENSUN PHARMACEUTICALS INC Terminated
Class II August 8, 2018 Doxycycline Hyclate Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons,… Failed Dissolution Specifications MAJOR PHARMACEUTICALS Terminated
Class III August 1, 2018 Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex… Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. Aidarex Pharmaceuticals LLC Terminated
Class II August 1, 2018 Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. MAJOR PHARMACEUTICALS Terminated
Class II August 1, 2018 Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Teva Pharmaceuticals USA Ongoing
Class II August 1, 2018 Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Teva Pharmaceuticals USA Ongoing
Class III August 1, 2018 Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex… Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. Aidarex Pharmaceuticals LLC Terminated
Class II August 1, 2018 Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Teva Pharmaceuticals USA Ongoing
Class II August 1, 2018 Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Teva Pharmaceuticals USA Ongoing
Class III August 1, 2018 Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex… Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. Aidarex Pharmaceuticals LLC Terminated
Class II August 1, 2018 Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. MAJOR PHARMACEUTICALS Terminated
Class II August 1, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Teva Pharmaceuticals USA Ongoing
Class II August 1, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Teva Pharmaceuticals USA Ongoing
Class II August 1, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Teva Pharmaceuticals USA Ongoing
Class II August 1, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Teva Pharmaceuticals USA Ongoing
Class II August 1, 2018 Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Teva Pharmaceuticals USA Ongoing
Class III August 1, 2018 Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx… Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the… MAJOR PHARMACEUTICALS Terminated
Class III August 1, 2018 Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx… Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the… MAJOR PHARMACEUTICALS Terminated
Class II August 1, 2018 Valsartan Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Prinston Pharmaceutical Inc Ongoing
Class II August 1, 2018 Valsartan Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Prinston Pharmaceutical Inc Ongoing
Class II August 1, 2018 Valsartan and Hydrochlorothiazide Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Prinston Pharmaceutical Inc Ongoing
Class II August 1, 2018 Valsartan Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Prinston Pharmaceutical Inc Ongoing
Class II August 1, 2018 Valsartan and Hydrochlorothiazide Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Prinston Pharmaceutical Inc Ongoing
Class II August 1, 2018 Valsartan Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Prinston Pharmaceutical Inc Ongoing
Class II August 1, 2018 Valsartan and Hydrochlorothiazide Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Prinston Pharmaceutical Inc Ongoing
Class II August 1, 2018 Testosterone Cypionate Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by:… Presence of Particulate Matter: organic and inorganic compounds detected in vials of product. Sun Pharmaceutical Industries, Inc. Terminated
Class II August 1, 2018 Valsartan and Hydrochlorothiazide Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Prinston Pharmaceutical Inc Ongoing
Class II August 1, 2018 Valsartan and Hydrochlorothiazide Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets,… CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Prinston Pharmaceutical Inc Ongoing
Class II July 25, 2018 EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag.… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL.… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL)… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf… Incorrect Product Formulation: wrong sunscreen product in the package. The Hain Celestial Group, Inc. - Worldwide HQ Terminated
Class II July 25, 2018 NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP)… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP)… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP)… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL.… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL).… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL)… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF,… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL)… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL… Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product… La Vita Compounding Pharmacy, LLC Terminated
Class II July 25, 2018 Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL… Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product… La Vita Compounding Pharmacy, LLC Terminated
Class II July 25, 2018 fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacaine HCL PF,… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag.… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL.… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume:… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume:… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj.,… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL).… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume:… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL).… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride,… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged… Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product… La Vita Compounding Pharmacy, LLC Terminated
Class II July 25, 2018 HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride (USP) QS 100… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL).… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj.,… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (USP) QS 30… Lack of Assurance of Sterility: Potential leakage of bags. Avella of Deer Valley, Inc. Store 38 Terminated
Class II July 25, 2018 Metformin Hydrochloride Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count… Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count)… Sun Pharmaceutical Industries, Inc. Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Bali Gold, 1oz, 250g 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Green Malay, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Red Kapuas Hulu , 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Green Kapuas Hulu, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class II July 18, 2018 Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured… Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below… Teva Pharmaceuticals USA Terminated
Class II July 18, 2018 Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and… CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good… Medgyn Products, Inc. Terminated
Class II July 18, 2018 Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use… Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding. SCA Pharmaceuticals Terminated
Class II July 18, 2018 Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only,… CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL. Medi-Fare Drug and Home Health Center Terminated
Class III July 18, 2018 Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a… Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant AMERICAN HEALTH PACKAGING Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Green Dragon, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Elephant, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Yellow Thai, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg packages,… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Yellow Vietnam, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, White Thai, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Green Thai, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, White MD, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Ganesh, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Red Horn, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Red Dragon, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, Green MD, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, White Horn, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class I July 18, 2018 Gaia Kratom (mitragyna speciosa) powder, White Borneo, 1oz, 250g, 1kg packages, Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC Terminated
Class III July 18, 2018 Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx… Subpotent Drug Mylan Pharmaceuticals Inc. Terminated
Class II July 18, 2018 Nitrofurantoin Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by:… Subpotent Drug and Failed Content Uniformity. LUPIN SOMERSET Terminated
Class II July 18, 2018 Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc.,… CGMP Deviations Akorn, Inc. Terminated
Class III July 18, 2018 Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container… Failed Impurities/Degradation Specifications Wockhardt Limited Terminated
Class III July 18, 2018 Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container… Failed Impurities/Degradation Specifications Wockhardt Limited Terminated
Class II July 18, 2018 ADMELOG Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in… Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature. Sanofi-Aventis U.S. LLC Ongoing
Class I July 18, 2018 Piperacillin and Tazobactam Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx… Presence of Particulate Matter: identified as glass and silicone material AuroMedics Pharma LLC Terminated
Class II July 11, 2018 Irinotecan Hydrochloride Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose… Superpotent Drug: High out of specification assay value results for potency. Ingenus Pharmaceuticals Llc Terminated
Class III July 11, 2018 Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC,… Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene… LUPIN SOMERSET Terminated
Class I July 11, 2018 Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled… Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be… Fagron Compounding Services LLC dba Fagron Sterile Services Terminated
Class II July 11, 2018 Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA… Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a… SCA Pharmaceuticals, LLC Terminated
Class II July 11, 2018 Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA… Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a… SCA Pharmaceuticals, LLC Terminated
Class III July 11, 2018 TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844… Labeling: Incorrect or Missing Lot and/or Exp Date. Qualgen, LLC Terminated
Class II July 11, 2018 Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA… Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a… SCA Pharmaceuticals, LLC Terminated
Class III July 11, 2018 ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844… Labeling: Incorrect or Missing Lot and/or Exp Date. Qualgen, LLC Terminated
Class I July 11, 2018 Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled… Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be… Fagron Compounding Services LLC dba Fagron Sterile Services Terminated
Class II July 11, 2018 Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA… Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a… SCA Pharmaceuticals, LLC Terminated
Class II July 11, 2018 Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA… Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a… SCA Pharmaceuticals, LLC Terminated
Class II July 11, 2018 Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals,… Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a… SCA Pharmaceuticals, LLC Terminated
Class II July 11, 2018 Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA… Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a… SCA Pharmaceuticals, LLC Terminated
Class II July 11, 2018 Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA… Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a… SCA Pharmaceuticals, LLC Terminated
Class II July 11, 2018 Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL)… Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a… SCA Pharmaceuticals, LLC Terminated
Class II July 11, 2018 Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA… Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a… SCA Pharmaceuticals, LLC Terminated
Class II July 11, 2018 Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL… Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a… SCA Pharmaceuticals, LLC Terminated
Class II July 11, 2018 Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA… Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a… SCA Pharmaceuticals, LLC Terminated
Class II July 11, 2018 eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone.… Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity Eb5 Corporation Terminated
Class II July 11, 2018 Irinotecan Hydrochloride Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose… Superpotent Drug: High out of specification assay value results for potency. Ingenus Pharmaceuticals Llc Terminated
Class II July 4, 2018 fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled… Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label. Advanced Pharma Inc. Terminated
Class III June 27, 2018 Atorvastatin Calcium Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's… Failed Impurities/Degradation Specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II June 27, 2018 Atorvastatin Calcium Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's… Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object… Dr. Reddy's Laboratories, Inc. Terminated