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
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class II | July 3, 2019 | Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged… | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | American Health Packaging | Terminated |
| Class II | July 3, 2019 | Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL… | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… | Premier Pharmacy Labs Inc | Terminated |
| Class II | July 3, 2019 | Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier… | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… | Premier Pharmacy Labs Inc | Terminated |
| Class II | July 3, 2019 | Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only,… | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… | Premier Pharmacy Labs Inc | Terminated |
| Class II | July 3, 2019 | Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx… | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | American Health Packaging | Terminated |
| Class II | July 3, 2019 | Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile… | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… | Premier Pharmacy Labs Inc | Terminated |
| Class III | June 26, 2019 | Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules… | Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label… | Akorn Inc | Terminated |
| Class II | June 26, 2019 | Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets,… | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance… | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class II | June 26, 2019 | Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye… | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the… | P & L Developments, LLC | Terminated |
| Class II | June 26, 2019 | Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr,… | CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Preferred Pharmaceuticals, Inc | Terminated |
| Class II | June 26, 2019 | Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release… | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance… | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class III | June 26, 2019 | QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz cans,… | Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material. | Ecolab Inc | Terminated |
| Class II | June 26, 2019 | Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets,… | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance… | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class II | June 26, 2019 | Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release… | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance… | Sun Pharmaceutical Industries, Inc. | Terminated |
| Class II | June 26, 2019 | Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape… | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the… | P & L Developments, LLC | Terminated |
| Class II | June 26, 2019 | Anastrozole Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | June 26, 2019 | Anastrozole ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | June 26, 2019 | Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten… | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the… | P & L Developments, LLC | Terminated |
| Class II | June 26, 2019 | Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by:… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class III | June 26, 2019 | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC… | Failed Impurities/Degradation Specifications | Teligent Pharma, Inc. | Terminated |
| Class II | June 26, 2019 | Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | June 26, 2019 | Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by:… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | June 26, 2019 | Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by:… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | June 26, 2019 | Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by:… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | June 26, 2019 | Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by:… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | June 26, 2019 | methylprednisolone MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | June 26, 2019 | methylprednisolone MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | June 26, 2019 | Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by:… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | June 26, 2019 | methylprednisolone MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | June 26, 2019 | Anastrozole Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged… | GMP Deviations: Potential cross contamination due to cleaning procedure failure. | American Health Packaging | Terminated |
| Class II | June 26, 2019 | methylprednisolone MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | June 26, 2019 | methylprednisolone MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in… | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | June 19, 2019 | Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL.… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West,… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15,… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free,… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC… | Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported | Geritrex, LLC | Terminated |
| Class II | June 19, 2019 | Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc | Terminated |
| Class II | June 19, 2019 | Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant,… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C,… | Lack of Processing Controls. | Synthetopes Inc | Terminated |
| Class II | June 19, 2019 | RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06,… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South Loop West,… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Bisacodyl Suppositories, Brite Stock, Reese. | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature,… | Lack of Processing Controls. | Synthetopes Inc | Terminated |
| Class II | June 19, 2019 | Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store… | Lack of Processing Controls. | Synthetopes Inc | Terminated |
| Class II | June 19, 2019 | Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC:… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle,… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room… | Lack of Processing Controls. | Synthetopes Inc | Terminated |
| Class III | June 19, 2019 | Ondansetron Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC,… | Failed Impurities/Degradation Specifications. | Fresenius Kabi USA, LLC | Terminated |
| Class II | June 19, 2019 | Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 1304 South Loop… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at… | Lack of Processing Controls. | Synthetopes Inc | Terminated |
| Class II | June 19, 2019 | Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals… | Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported | Geritrex, LLC | Terminated |
| Class II | June 19, 2019 | Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by:… | Failed Dissolution Specifications: Out of specification result for dissolution. | Chiesi USA, Inc. | Terminated |
| Class II | June 19, 2019 | Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL)… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant,… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC:… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC:… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only,… | Failed Dissolution Specifications: Out of specification result for dissolution. | Chiesi USA, Inc. | Terminated |
| Class II | June 19, 2019 | Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC:… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL,… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL,… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class I | June 19, 2019 | Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24… | Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil | SELECT DISTRIBUTIONS LLC | Terminated |
| Class II | June 19, 2019 | Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg),… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston,… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc. | Lack of Processing Controls. | Synthetopes Inc | Terminated |
| Class II | June 19, 2019 | Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl,… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg,… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston,… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D.… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant, One Pint… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL) bottle,… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304 South Loop… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 4 FL.… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West,… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston,… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle,… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC:… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West,… | Lack of Sterility Assurance. | Pharm D Solutions, LLC | Terminated |
| Class II | June 19, 2019 | Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz.… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.)… | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R.… | Torrent Pharma Inc | Terminated |
| Class II | June 19, 2019 | Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store… | Lack of Processing Controls. | Synthetopes Inc | Terminated |
| Class I | June 19, 2019 | Prochlorperazine Edisylate PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by:… | Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and… | Heritage Pharmaceuticals, Inc. | Terminated |
| Class III | June 19, 2019 | Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch &… | Failed Stability Specifications: Out of specification for viscosity. | Bausch & Lomb | Terminated |
| Class I | June 19, 2019 | Amikacin Sulfate AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by:… | Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and… | Heritage Pharmaceuticals, Inc. | Terminated |
| Class II | June 19, 2019 | ESTRADIOL VAGINAL INSERTS Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with… | Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly. | Glenmark Pharmaceuticals Inc., USA | Terminated |
| Class I | June 19, 2019 | Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec… | Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due… | Novis PR, Inc. | Terminated |
| Class II | June 19, 2019 | Sevoflurane Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter… | Failed Stability Specifications | Baxter Healthcare Corporation | Terminated |
| Class II | June 19, 2019 | Heparin Sodium in Dextrose Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose… | Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended… | B. Braun Medical Inc | Terminated |
| Class II | June 5, 2019 | Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump… | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd | Terminated |
| Class II | June 5, 2019 | INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX,… | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd | Terminated |
| Class II | June 5, 2019 | Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz… | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd | Terminated |
| Class II | June 5, 2019 | Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY… | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 | Terminated |
| Class II | June 5, 2019 | ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap,… | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd | Terminated |
| Class II | June 5, 2019 | Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant… | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd | Terminated |
| Class II | June 5, 2019 | Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml… | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd | Terminated |
| Class II | June 5, 2019 | INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11),… | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd | Terminated |
| Class II | June 5, 2019 | AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1%… | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd | Terminated |
| Class II | June 5, 2019 | Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with… | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd | Terminated |
| Class II | June 5, 2019 | Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan,… | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. | Inopak Ltd | Terminated |
| Class I | June 5, 2019 | The Beast, The Beast can be taken under the situation of Heart disease and even after… | Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA… | Stiff Boy LLC | Terminated |
| Class II | June 5, 2019 | Cefdinir Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx… | Complaint received of metal piece identified in the product bottle prior to the reconstitution. | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | May 29, 2019 | Amitiza Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by:… | Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade… | MALLINCKRODT PHARMACEUTICALS | Terminated |
| Class II | May 29, 2019 | Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Heritage Pharmaceuticals, Inc. | Terminated |
| Class II | May 29, 2019 | Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by:… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Heritage Pharmaceuticals, Inc. | Terminated |
| Class II | May 29, 2019 | Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Golden State Medical Supply Inc. | Terminated |
| Class II | May 29, 2019 | Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Heritage Pharmaceuticals, Inc. | Terminated |
| Class II | May 29, 2019 | Amitiza Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by:… | Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade… | MALLINCKRODT PHARMACEUTICALS | Terminated |
| Class II | May 29, 2019 | Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Golden State Medical Supply Inc. | Terminated |
| Class II | May 29, 2019 | Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Golden State Medical Supply Inc. | Terminated |
| Class II | May 29, 2019 | Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by:… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Heritage Pharmaceuticals, Inc. | Terminated |
| Class II | May 29, 2019 | Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by:… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Heritage Pharmaceuticals, Inc. | Terminated |
| Class II | May 29, 2019 | Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Golden State Medical Supply Inc. | Terminated |
| Class II | May 29, 2019 | Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Golden State Medical Supply Inc. | Terminated |
| Class I | May 29, 2019 | PROMACTA Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo… | Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut… | Novartis Pharmaceuticals Corp. | Terminated |
| Class II | May 29, 2019 | Articadent Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7… | Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in… | Septodont Inc. | Terminated |
| Class II | May 22, 2019 | Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Preferred Pharmaceuticals, Inc | Terminated |
| Class I | May 22, 2019 | Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt,… | Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil. | D.B.P. Distribution | Terminated |
| Class II | May 22, 2019 | CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough… | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… | Unipharma, Llc. | Terminated |
| Class II | May 22, 2019 | DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use… | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… | Unipharma, Llc. | Terminated |
| Class II | May 22, 2019 | CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer… | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… | Unipharma, Llc. | Terminated |
| Class II | May 22, 2019 | CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer… | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… | Unipharma, Llc. | Terminated |
| Class II | May 22, 2019 | CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple… | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… | Unipharma, Llc. | Terminated |
| Class II | May 22, 2019 | DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured… | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… | Unipharma, Llc. | Terminated |
| Class II | May 22, 2019 | DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured… | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… | Unipharma, Llc. | Terminated |
| Class II | May 22, 2019 | DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100… | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… | Unipharma, Llc. | Terminated |
| Class II | May 22, 2019 | DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20… | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… | Unipharma, Llc. | Terminated |
| Class II | May 22, 2019 | CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough… | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… | Unipharma, Llc. | Terminated |
| Class II | May 22, 2019 | CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL… | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… | Unipharma, Llc. | Terminated |
| Class III | May 22, 2019 | Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister… | Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets,… | Pfizer Inc. | Terminated |
| Class II | May 15, 2019 | Carvedilol Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila… | Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained… | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | May 15, 2019 | Acyclovir Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila… | Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained… | Zydus Pharmaceuticals USA Inc | Terminated |
| Class I | May 15, 2019 | Fentanyl system FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only,… | Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five… | Alvogen, Inc | Terminated |
| Class II | May 15, 2019 | KETOROLAC TROMETHAMINE Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx… | Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which… | Sagent Pharmaceuticals Inc | Terminated |
| Class I | May 15, 2019 | mycophenolate mofetil Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only,… | Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product | Par Pharmaceutical, Inc. | Terminated |
| Class II | May 8, 2019 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Torrent Pharma Inc. | Ongoing |
| Class II | May 8, 2019 | Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20… | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding | Terminated |
| Class II | May 8, 2019 | Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL… | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding | Terminated |
| Class III | May 8, 2019 | Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%;… | Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz.… | Advantice Health | Terminated |
| Class II | May 8, 2019 | Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL… | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding | Terminated |
| Class II | May 8, 2019 | Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Torrent Pharma Inc. | Ongoing |
| Class II | May 8, 2019 | Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | RemedyRepack Inc. | Terminated |
| Class II | May 8, 2019 | Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML… | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding | Terminated |
| Class II | May 8, 2019 | HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium… | Sub-potency | Advanced Pharma Inc. | Terminated |
| Class II | May 8, 2019 | HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded.… | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding | Terminated |
| Class II | May 8, 2019 | BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biologic product… | Defective Delivery System: difficult to express | Pacifico National, Inc. dba AmEx Pharmacy | Terminated |
| Class II | May 8, 2019 | Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Torrent Pharma Inc. | Ongoing |
| Class II | May 8, 2019 | GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and… | Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were… | American Health Packaging | Terminated |
| Class II | May 8, 2019 | BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML),… | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding | Terminated |
| Class II | May 8, 2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The… | CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active… | Legacy Pharmaceutical Packaging LLC | Ongoing |
| Class III | May 8, 2019 | Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%,… | Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net… | Advantice Health | Terminated |
| Class II | May 8, 2019 | Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant… | Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability… | US Worldmeds LLC | Terminated |
| Class II | May 8, 2019 | Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | AVKARE Inc. | Ongoing |
| Class II | May 8, 2019 | Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | AVKARE Inc. | Ongoing |
| Class II | May 8, 2019 | Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML), 5 ML… | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding | Terminated |
| Class II | May 8, 2019 | TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7… | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding | Terminated |
| Class II | May 8, 2019 | BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML),… | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding | Terminated |
| Class II | May 8, 2019 | Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded.… | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding | Terminated |
| Class II | May 8, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC:… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Torrent Pharma Inc. | Ongoing |
| Class II | May 8, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC:… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Torrent Pharma Inc. | Ongoing |
| Class II | May 8, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC:… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Torrent Pharma Inc. | Ongoing |
| Class III | May 1, 2019 | Carvedilol Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila… | Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a… | Zydus Pharmaceuticals USA Inc | Terminated |
| Class II | May 1, 2019 | CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class III | May 1, 2019 | Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL… | Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%)… | Akorn Inc | Terminated |
| Class II | May 1, 2019 | Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive,… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive,… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive,… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive,… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy,… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive,… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, Made by:… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive,… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive,… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class II | May 1, 2019 | Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres… | Lack of sterility assurance. | CMC Enterprise Pharmacy | Terminated |
| Class III | May 1, 2019 | Morphine Sulfate Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only,… | Failed Impurities/Degradation Specifications | LUPIN SOMERSET | Terminated |
| Class III | May 1, 2019 | Morphine Sulfate Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by:… | Failed Impurities/Degradation Specifications | LUPIN SOMERSET | Terminated |
| Class III | May 1, 2019 | Morphine Sulfate Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only,… | Failed Impurities/Degradation Specifications | LUPIN SOMERSET | Terminated |
| Class III | May 1, 2019 | Morphine Sulfate Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only,… | Failed Impurities/Degradation Specifications | LUPIN SOMERSET | Terminated |
| Class III | May 1, 2019 | Morphine Sulfate Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only,… | Failed Impurities/Degradation Specifications | LUPIN SOMERSET | Terminated |
| Class II | April 24, 2019 | DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe,… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Sermorelin 0.3 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Sermorelin 0.4 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Methionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine 10 mg,… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Methylcobalamin 1 mg/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Prostaglandin 60 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol,… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Morphine Sulfate 5 mg/3mL Inhalation, 3 mL Vials, Anderson Compounding Pharmacy 310 Bluff… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Prostaglandin 40 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol,… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Prostaglandin Quad-Mix 20:30:1:0.15 Injection, 10 mL Vial, Anderson Compounding Pharmacy… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 mL, 60… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Bacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | HCG 40 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Estradiol Cypionate 10 mg/mL, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Penicillin G 100,000/mL 10 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy,… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Phenylephrine 1 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, Anderson Compounding Pharmacy 310… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Prostaglandin Tri-Mix 50:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL,… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, Anderson… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | HCG 23 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Testosterone Cypionate 250 mg/mL Sterile Injection, 5 mL Vial, Anderson Compounding… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |
| Class II | April 24, 2019 | Prostaglandin Quad with Atropine 10:30:1:0.15, 2 mL Vial, Anderson Compounding Pharmacy… | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy | Terminated |