Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1516-2020 | 07-27-2020 | Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Accord Healthcare, Inc., Durham NC 27703; NDC 16729-0184-17 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1527-2020 | 07-27-2020 | Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0202-70 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1549-2020 | 07-27-2020 | HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) plastic containers, Distributed by: Resource Recovery & Trading LLC 4275 Executive Square, Ste. 200 La Jolla, CA 92037, UPC 37710600013 | cGMP deviations | RESOURCE RECOVERY & TRADING LLC / 115 bottles | Class II | Completed |
| D-1515-2020 | 07-27-2020 | Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Unichem Pharmaceuticals, NDC 29300-0128-10 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1526-2020 | 07-27-2020 | Phentermine HCL GrayYellow capsules, 15mg, packaged in a) 28-count bags and b) 56-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0203-70 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1514-2020 | 07-27-2020 | Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare, Inc, Durham, NC 27703, NDC 16729-0183-17 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1518-2020 | 07-27-2020 | Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs Cave Creek, AZ 85331, NDC 64727-3300-01 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1520-2020 | 07-27-2020 | Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13 | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1522-2020 | 07-27-2020 | Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm, LLC. | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1578-2020 | 07-27-2020 | HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706 91368 6; b) 8.4 fl. oz. (250 ml) bottle, UPC 714706 91367 9; c) 33.8 fl. oz. (1 Liter) bottle, UPC 7 14706 91365 5; , Made in Mexico by: Broncolin, S.A. de C.V. Sur 16 No. 353, Col. Agricola Oriental, Iztacalco, C.P. 08500, Cuidad de Mexico, Mexico. Importer/Distributor: INBC TRADING LLC 4404 Merle Drive, Austin, TX 78745. | Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol. | Broncolin, S.A. de C.V. / 26,972 bottle | Class I | Terminated |
| D-1577-2020 | 07-27-2020 | HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706 91368 6; b) 8.4 fl. oz. (250 ml) bottle, UPC 714706 91367 9; c) 16.9 fl. oz. (500 ml) bottle, UPC 7 14706 91366 2; and d) 33.8 fl. oz. (1 Liter) bottle, UPC 7 14706 91365 5; Made in Mexico by: Broncolin, S.A. de C.V. Sur 16 No. 353, Col. Agricola Oriental, Iztacalco, C.P. 08500, Cuidad de Mexico, Mexico. Importer/Distributor: INBC TRADING LLC 4404 Merle Drive, Austin, TX 78745 | CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Broncolin, S.A. de C.V. / 482,416 bottles | Class II | Terminated |
| D-1497-2020 | 07-24-2020 | Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012. | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity. | Golden State Medical Supply Inc. / N/A | Class III | Terminated |
| D-1487-2020 | 07-24-2020 | VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyamine sulfate), Rx Only, 100 Capsules per Bottle, Manufactured for: Vilvet Pharmaceuticals Inc., Chester Springs, PA 18425, NDC 71186-002-35. | cGMP deviations | Vilvet Pharmaceuticals Inc. / 11,640 bottles | Class II | Terminated |
| D-1488-2020 | 07-24-2020 | VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine sulfate and 32.4 mg phenyl salicylate), Rx Only, 90 Tablets per Bottle, Manufactured for: Vilvet Pharmaceuticals, Inc., Chester Springs, PA 19425, NDC 71186-000-24. | cGMP deviations | Vilvet Pharmaceuticals Inc. / 1,716 bottles | Class II | Terminated |
| D-1583-2020 | 07-23-2020 | BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3, Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018. | Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Real Clean Distribuciones SA de CV / N/A | Class I | Terminated |
| D-1579-2020 | 07-23-2020 | scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL, Distributed by Scent Theory Products, LLC New York, NY 10018, Made in Mexico, UPC 8 40038 21434 1 | CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Real Clean Distribuciones SA de CV / 504,000 pieces | Class II | Terminated |
| D-1582-2020 | 07-23-2020 | LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed by: Procurement Services, LLC Nashville, TN 37215, Product of Mexico. NDC 74882-007-02 | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Real Clean Distribuciones SA de CV / 90,288 bottles | Class II | Terminated |
| D-1581-2020 | 07-23-2020 | BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL OZ (1L) bottle, UPC 8 40038 21447 1; Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018. | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Real Clean Distribuciones SA de CV / 975,720 bottles | Class II | Terminated |
| D-1580-2020 | 07-23-2020 | scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcohol 70%), 16.9 FL OZ/500 mL bottle, Distributed by Scent Theory Products, LLC New York, NY 10018. Made in Mexico, UPC 8 40038 21434 1 | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. | Real Clean Distribuciones SA de CV / 917,280 bottles | Class II | Terminated |
| D-1537-2020 | 07-22-2020 | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05 | Cross Contamination with other products: trace amounts of lidocaine | Fresenius Kabi USA, LLC / 25,100 bottles | Class I | Terminated |
| D-1490-2020 | 07-22-2020 | Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10 Package NDCs: 0054-4496-25; 0054-4496-13; 0054-4497-10; 0054-4497-05; 0054-4498-10; 0054-4499-11; 0054-8496-19 | Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code. | West-Ward Columbus Inc / 2300 bottles | Class III | Terminated |
| D-1506-2020 | 07-21-2020 | STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC 0053-6871-00 | Superpotent Drug | Ferring Pharmaceuticals Inc / 29,371 nasal sprays | Class I | Terminated |
| D-1504-2020 | 07-21-2020 | DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0 | Superpotent Drug | Ferring Pharmaceuticals Inc / 15,175 nasal sprays | Class I | Terminated |
| D-1505-2020 | 07-21-2020 | Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS INC., Berwyn, PA 19312, NDC 69918-501-05 | Superpotent Drug | Ferring Pharmaceuticals Inc / 184,325 nasal sprays | Class I | Terminated |
| D-1502-2020 | 07-21-2020 | Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each, NDC: 68180-911-13, Distributed by: Lupin Pharmaceuticals, Inc., MD, 21200, Manufactured by: Lupin Limited, India. | Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test. | Lupin Pharmaceuticals Inc. / 560,922 Pouches | Class II | Terminated |
| D-1496-2020 | 07-20-2020 | Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012. | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity. | Taro Pharmaceuticals U.S.A., Inc. / 7632 tubes | Class III | Terminated |
| D-0254-2021 | 07-20-2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) drum, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col.. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477.UPC # 7 501799 118998 | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Liq-E S.A. De C.V. / 575 drums | Class I | Terminated |
| D-0256-2021 | 07-20-2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L) tank with spout dispenser, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477.; UPC # 7 501799 118981 | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Liq-E S.A. De C.V. / 1 tank | Class I | Terminated |
| D-0253-2021 | 07-20-2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (250 mL) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477. UPC # 7 501799 115621 | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Liq-E S.A. De C.V. / 12,201 bottles | Class I | Terminated |
| D-0255-2021 | 07-20-2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477; NDC: XXXXX-378-04, UPC # 7 501799 118837 | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Liq-E S.A. De C.V. / 6,597 gallons | Class I | Terminated |
| D-1446-2020 | 07-20-2020 | Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12 Package NDCs: 0409-9093-41; 0409-9093-36; 0409-9093-31; 0409-9093-38; 0409-9094-12; 0409-9094-22; 0409-9094-18; 0409-9094-25; 0409-9094-17; 0409-9094-28; 0409-9094-16; 0409-9094-31; 0409-9094-41; 0409-9094-61; 0409-9094-44; 0409-9094-55 | Lack of Assurance of Sterility; potential loose metal overseal crimp defects. | Pfizer Inc. / 19,144 vials | Class II | Terminated |
| D-1413-2020 | 07-17-2020 | Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08 Package NDCs: 68001-337-00; 68001-337-08; 68001-332-00; 68001-332-03; 68001-333-00; 68001-333-08; 68001-486-00; 68001-486-08; 68001-334-00; 68001-334-08; 68001-335-00; 68001-335-08; 68001-336-00 | Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg | Lupin Pharmaceuticals Inc. / 11,688 bottles | Class II | Terminated |
| D-1558-2020 | 07-16-2020 | HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biologicals, Inc. 469 W. Parkland Drive, Sandy, UT 84070, NDC: 43742-1299-1 | Labeling: Error on Declared Strength | Grato Holdings, Inc. / 850 bottles | Class II | Terminated |
| D-1560-2020 | 07-14-2020 | Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7 | cGMP Deviations | Soluciones Cosmeticas, SA de CV / 2,486,400 bottles | Class II | Terminated |
| D-1492-2020 | 07-14-2020 | Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30 Package NDCs: 0591-3525-11; 0591-3525-30 | Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton. | Teva Pharmaceuticals USA / 28,596 cartons | Class II | Terminated |
| D-0054-2021 | 07-13-2020 | Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15 | SUBPOTENT DRUG | Bausch Health Companies, Inc. / 35424 units | Class II | Terminated |
| D-1391-2020 | 07-13-2020 | Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10 Package NDCs: 63323-972-10 | Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial. | Fresenius Kabi USA, LLC / 63,067 vials | Class III | Terminated |
| D-0029-2021 | 07-11-2020 | blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6 c) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3. Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class I | Terminated |
| D-0022-2021 | 07-11-2020 | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bottle, UPC 8 14266 02374 7, Distributed in USA and Canada BY: 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico. | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
| D-0025-2021 | 07-11-2020 | blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. UPC 8 14266 02358 7 | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
| D-0031-2021 | 07-11-2020 | blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4, b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class I | Terminated |
| D-0027-2021 | 07-11-2020 | ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) 10 fL oz / 295 ml bottle, UPC 6 39277 49070 4, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
| D-0026-2021 | 07-11-2020 | ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10 fL oz / 296 ml bottle, UPC 6 39277 49069 8, Distributed by Geenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
| D-0023-2021 | 07-11-2020 | blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b) 7.5 fl. oz./221 ml bottle, UPC 8 14266 02362 4 b) 33.8 fl. oz./1L bottle, UPC 8 14266 02369 3, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
| D-0030-2021 | 07-11-2020 | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz / 1 L bottle, Distributed in USA and Canada by: 4e Brands 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico. UPC 8 14266 02374 7 | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content. | 4e Brands North America, Llc / N/A | Class I | Terminated |
| D-0028-2021 | 07-11-2020 | Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico. UPC 0 32251 49935 7 | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
| D-0024-2021 | 07-11-2020 | blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4 c) 15.2 fl oz (450 ml) bottle, UPC 8 14266 02392 1, d) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6, e) 18 fl oz / 532 ml bottle, UPC 8 14266 02391 4, f) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3 g) 70 fl oz / 2.07L bottle, UPC 8 14266 02367 9 h) 1.05 GAL / 4L bottle, UPC 8 14266 02368 6; Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices. | 4e Brands North America, Llc / 17,359,247 total bottles and pumps | Class II | Terminated |
| D-1389-2020 | 07-10-2020 | Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01. Package NDCs: 59922-631-01 | cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia. | Keryx Biopharmaceuticals, Inc. / 59,820 bottles | Class II | Terminated |
| D-1565-2020 | 07-09-2020 | Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 54665 NDC 76753-001-01 | CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol. | Maquiladora Miniara Sa De Cv / 245,500 bottles | Class II | Terminated |
| D-1484-2020 | 07-07-2020 | Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50 Package NDCs: 67457-813-50 | Presence of Particulate Matter | Mylan Institutional LLC / 18,480 vials | Class I | Terminated |
| D-0268-2021 | 07-07-2020 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415 Package NDCs: 54365-400-33 | Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 400 cartons | Class I | Terminated |
| D-0265-2021 | 07-07-2020 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400 Package NDCs: 54365-400-32 | Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 988 cartons | Class I | Terminated |
| D-0266-2021 | 07-07-2020 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415 | Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 36 cartons | Class I | Terminated |
| D-1385-2020 | 07-07-2020 | Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Lupin Pharmaceuticals Inc. / 273,060 bottles | Class II | Terminated |
| D-1382-2020 | 07-07-2020 | Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Lupin Pharmaceuticals Inc. / 64,344 bottles | Class II | Terminated |
| D-1383-2020 | 07-07-2020 | Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Lupin Pharmaceuticals Inc. / 95,886 bottles | Class II | Terminated |
| D-1384-2020 | 07-07-2020 | Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Lupin Pharmaceuticals Inc. / 59,568 bottles | Class II | Terminated |
| D-0267-2021 | 07-07-2020 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400 | Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity. | CareFusion 213, LLC / 280 cartons | Class I | Terminated |
| D-1445-2020 | 07-06-2020 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86 | Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine | SUN PHARMACEUTICAL INDUSTRIES INC / 3516 bottles | Class III | Terminated |
| D-1409-2020 | 07-06-2020 | Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02 | SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. | Allergan PLC / 4,018 bottles | Class III | Terminated |
| D-1410-2020 | 07-06-2020 | Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005 | SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. | Allergan PLC / 8,555 kits | Class III | Terminated |
| D-1386-2020 | 07-03-2020 | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India Package NDCs: 70010-491-01; 70010-491-05; 70010-491-10; 70010-491-18; 70010-491-19; 70010-491-09; 70010-492-01; 70010-492-05; 70010-492-20; 70010-492-21 | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Granules Pharmaceuticals Inc / a) 476,073 bottles; b) 2,100 bottles | Class II | Ongoing |
| D-1406-2020 | 07-02-2020 | Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20 Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples. | Lupin Pharmaceuticals Inc. / 35,928 bottles | Class II | Terminated |
| D-1419-2020 | 07-02-2020 | D-Biotin 300 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 390 capsules | Class II | Terminated |
| D-1431-2020 | 07-02-2020 | Progesterone 200 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 300 troches | Class II | Terminated |
| D-1438-2020 | 07-02-2020 | Tadalafil 26 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 900 capsules | Class II | Terminated |
| D-1429-2020 | 07-02-2020 | Progesterone 300 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 90 trouches | Class II | Terminated |
| D-1434-2020 | 07-02-2020 | Progesterone Modified Release 200 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 900 capsules | Class II | Terminated |
| D-1427-2020 | 07-02-2020 | Progesterone (Modified Release) 150 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 600 capsules | Class II | Terminated |
| D-1443-2020 | 07-02-2020 | Yohimbine HCL 5.4mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 90 capsules | Class II | Terminated |
| D-1439-2020 | 07-02-2020 | Tadalafil 3 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 900 capsules | Class II | Terminated |
| D-1440-2020 | 07-02-2020 | Tadalafil 7 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 12000 capsules | Class II | Terminated |
| D-1570-2020 | 07-02-2020 | bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5 | Chemical Contamination: Product contains methanol. | AAA Cosmetica, SA de CV / 204,768 bottles | Class I | Terminated |
| D-1432-2020 | 07-02-2020 | Progesterone 50 mg Modified Release Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 300 capsules | Class II | Terminated |
| D-1422-2020 | 07-02-2020 | Finasteride Plus 1.25mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 29580 capsules | Class II | Terminated |
| D-1426-2020 | 07-02-2020 | Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 1200 capsules | Class II | Terminated |
| D-1421-2020 | 07-02-2020 | Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 300 capsules | Class II | Terminated |
| D-1435-2020 | 07-02-2020 | Sildenafil 50 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 80 troches | Class II | Terminated |
| D-1442-2020 | 07-02-2020 | Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 134 troches | Class II | Terminated |
| D-1420-2020 | 07-02-2020 | Estriol 6 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 90 capsules | Class II | Terminated |
| D-1433-2020 | 07-02-2020 | Progesterone Modified Release 100 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 600 capsules | Class II | Terminated |
| D-1430-2020 | 07-02-2020 | Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 288 tablets | Class II | Terminated |
| D-1418-2020 | 07-02-2020 | Calcium citrate tetrahydrate USP powder, 100 gm container, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 24 grams | Class II | Terminated |
| D-1437-2020 | 07-02-2020 | Tadalafil 18 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 900 capsules | Class II | Terminated |
| D-1569-2020 | 07-02-2020 | bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5 | CGMP Deviations | AAA Cosmetica, SA de CV / 21,228 bottles | Class II | Terminated |
| D-1423-2020 | 07-02-2020 | Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride 0.25%), 0.5 FL OZ (15 mL) bottle MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600. | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 462 units | Class II | Terminated |
| D-1424-2020 | 07-02-2020 | Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0.5 FL OZ (15 mL), b) 2 FL OZ (60 mL) bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 543 units | Class II | Terminated |
| D-1436-2020 | 07-02-2020 | Tadalafil 12 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 600 capsules | Class II | Terminated |
| D-1428-2020 | 07-02-2020 | Progesterone 150 mg Troche, 30 troches MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 330 troches | Class II | Terminated |
| D-1441-2020 | 07-02-2020 | Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419 (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 339 pellets | Class II | Terminated |
| D-1425-2020 | 07-02-2020 | Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600 | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC / 300 capsules | Class II | Terminated |
| D-1562-2020 | 07-02-2020 | Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01 | Labeling: Label Error on Declared Strength | Edge Pharma, LLC / 5 IV bags | Class II | Terminated |
| D-1503-2020 | 07-01-2020 | Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For Institutional and Industrial Use Only, a) foamyiQ 42.27 oz/1250 mL cartridge, UPC code: 7 53727 26454 4; b) Lite 'n Foamy 1 gallon/3.79 L container UPC code: 7 53727 26113 0, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. | Microbial contamination of non-sterile products: positive microbial contamination in product. | Spartan Chemical Co Inc / a) 60,796 cartridges, b) 420 gallon containers | Class I | Terminated |
| D-1390-2020 | 07-01-2020 | Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg Size 15 patches per box, Insurance NDC: 53225-1025-01, Mfg: Terrain Pharmaceuticals; Reno, NV, Prod # (NDC): 68788-7405-01, Preferred Pharmaceuticals, Inc., The Physicians Solutions. | CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch. | Preferred Pharmaceuticals, Inc. / N/A | Class II | Terminated |
| D-1387-2020 | 06-29-2020 | Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose. | FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing. | RemedyRepack Inc. / 498 tablets | Class II | Terminated |
| D-1408-2020 | 06-29-2020 | Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antiseptic Hand Rub, Non-sterile Solution, Extra strength Formula*, 8.45 fl. oz. (250 ml) bottle, Labeled with green or blue labels, Manufactured by Mystic Intl S.A. de C.V. UPC barcode: 7 87790 33952 6 | Chemical Contamination: Presence of Undeclared Methanol | Transliquid Technologies, LLC / 20,340 bottles | Class I | Terminated |
| D-1379-2020 | 06-29-2020 | Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1 Package NDCs: 44087-1225-1 | Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance. | EMD Serono, Inc. / 30,756 vials | Class II | Terminated |
| D-1412-2020 | 06-25-2020 | Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5. | CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol. | POLARIZED LLC / 18, 126 bottles | Class II | Terminated |
| D-1534-2020 | 06-24-2020 | Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0 | Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches | Medichem S.A. / 117,800 kg | Class I | Terminated |
| D-1538-2020 | 06-23-2020 | All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by Eskbiochem SA de CV Ave Mexico Japon 50 Celaya, Gto. Mexico 38010, Distributed by All Clean Natural LTD, UPC Code 6 28055 37013 0 | Chemical Contamination: Product contains undeclared methanol. | Itech 361 LLC / 18,760 bottles | Class I | Terminated |
