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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0051-2021 | 10-05-2020 | Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01 | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. / 13,270 bottles/100 tablets each | Class II | Terminated |
| D-0053-2021 | 10-05-2020 | Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01 | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. / N/A | Class II | Terminated |
| D-0714-2021 | 10-05-2020 | SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 41 mL | Class I | Terminated |
| D-0709-2021 | 10-05-2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 42 mL | Class I | Terminated |
| D-0052-2021 | 10-05-2020 | Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0007-01 | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. / N/A | Class II | Terminated |
| D-0715-2021 | 10-05-2020 | MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 21 mL | Class I | Terminated |
| D-0711-2021 | 10-05-2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 84 mL | Class I | Terminated |
| D-0712-2021 | 10-05-2020 | MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 21 mL | Class I | Terminated |
| D-0713-2021 | 10-05-2020 | MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 21 mL | Class I | Terminated |
| D-0717-2021 | 10-05-2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5MG/ML, m) 10MG-30MG/ML, n)15MG-1.6MG/ML, o) 20MG-30MG/ML, p)15MG-6MG/ML, q)15MG-27MG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 360 mL | Class I | Terminated |
| D-0708-2021 | 10-05-2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 126 mL | Class I | Terminated |
| D-0706-2021 | 10-05-2020 | FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 21 mL | Class I | Terminated |
| D-0704-2021 | 10-05-2020 | BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605 | Non-Sterility | Med Shop Total Care Inc. / 21 mL | Class I | Terminated |
| D-0055-2021 | 10-02-2020 | Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0 | Discoloration. | Medichem S.A. / 60,000 kg | Class II | Terminated |
| D-0049-2021 | 10-02-2020 | Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-3001-77; 0378-3002-77; 0378-3003-77; 0378-3002-05 | Out-of-specification organic impurity results obtained during routine stability testing. | Mylan Pharmaceuticals Inc. / 10,695 bottles | Class III | Terminated |
| D-0061-2021 | 10-02-2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50 Package NDCs: 49483-623-09; 49483-623-01; 49483-623-50; 49483-623-10; 49483-624-01; 49483-624-50 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Marksans Pharma Limited / a) 64,590 b) 23,834 c) 109,125 d) 27839 bottles | Class II | Terminated |
| D-0062-2021 | 10-02-2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01 Package NDCs: 49483-623-09; 49483-623-01; 49483-623-50; 49483-623-10; 49483-624-01; 49483-624-50 | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Marksans Pharma Limited / 368,976 bottles | Class II | Terminated |
| D-0098-2021 | 10-01-2020 | Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-144, UPC 8 50016 92321 9, NDC 70108-042-01); b) JoJo Siwa Dreamer (Item #: 92320-144, UPC 8 50016 92320 2, NDC 70108-044-01); c) Hot Wheels (Item #: 92317-144, UPC 8 50016 92317 2, NDC 70108-045-01); d) Barbie (Item #: 92318-144, UPC 8 50016 92318 9, NDC 70108-046-01); e) Trolls (Item #: 92322-144, UPC 8 50016 92322 6, NDC 70108-047-01); and f) Minions (Item #: 92319-144, UPC 8 50016 92319 6, NDC 70108-043-01); Distributed by Ashtel Studios Inc., Ontario, CA 91761 | Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches | ASHTEL STUDIOS, INC. / N/A | Class I | Terminated |
| D-0064-2021 | 09-28-2020 | Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310 | Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity. | Teligent Pharma, Inc. / 36,790 tubes | Class III | Terminated |
| D-0220-2021 | 09-25-2020 | Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9 | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. | Wishgarden Herbs, Incorporated / 298 jars | Class I | Terminated |
| D-0219-2021 | 09-25-2020 | Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4 | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. | Wishgarden Herbs, Incorporated / 1651 jars | Class I | Terminated |
| D-0218-2021 | 09-25-2020 | Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5 | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. | Wishgarden Herbs, Incorporated / 46 jars | Class I | Terminated |
| D-0019-2021 | 09-25-2020 | NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816, | Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot | VistaPharm, Inc. / 14,244 16 oz bottles | Class III | Terminated |
| D-0034-2021 | 09-24-2020 | Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01 Package NDCs: 54482-020-01; 54482-020-02; 54482-035-02 | Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl. | Leadiant Biosciences, Inc. / 1380 bottles | Class III | Terminated |
| D-0102-2021 | 09-24-2020 | SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 . | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol. | AA PRODUCTS INC / 1392 bottles | Class II | Completed |
| D-1626-2020 | 09-24-2020 | Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645-545-59 | Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles. | Legacy Pharmaceutical Packaging LLC / 111,948 bottles | Class III | Terminated |
| D-0002-2021 | 09-23-2020 | RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17 | CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product. | SUN PHARMACEUTICAL INDUSTRIES INC / 747 bottles | Class II | Terminated |
| D-0005-2021 | 09-17-2020 | Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets per bottle, Rx Only, Pkg By PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127, NDC 43063-819-01. | CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent. | PD-Rx Pharmaceuticals, Inc. / 20 bottles | Class II | Terminated |
| D-0099-2021 | 09-17-2020 | Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0756-1. | Labeling: Product Contains Undeclared API; Incorrect formulation | Grato Holdings, Inc. / 399 bottles | Class III | Terminated |
| D-0035-2021 | 09-17-2020 | NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01 Package NDCs: 42192-327-01; 42192-327-30; 42192-327-90; 42192-329-01; 42192-329-30; 42192-329-10; 42192-329-90; 42192-330-01; 42192-330-30; 42192-330-10; 42192-330-90; 42192-331-01; 42192-331-30; 42192-331-10; 42192-331-90; 42192-328-01; 42192-328-30; 42192-328-90 | Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product. | Acella Pharmaceuticals, LLC / 19,296 bottles | Class I | Terminated |
| D-0036-2021 | 09-17-2020 | NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01 Package NDCs: 42192-327-01; 42192-327-30; 42192-327-90; 42192-329-01; 42192-329-30; 42192-329-10; 42192-329-90; 42192-330-01; 42192-330-30; 42192-330-10; 42192-330-90; 42192-331-01; 42192-331-30; 42192-331-10; 42192-331-90; 42192-328-01; 42192-328-30; 42192-328-90 | Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product. | Acella Pharmaceuticals, LLC / 9816 bottles | Class I | Terminated |
| D-1594-2020 | 09-16-2020 | Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Pharma Drive, Morrisville, NC 27560, Distributed by: Perrigo, Allegan, MI 49010 NDC 45802-088-01 Package NDCs: 45802-088-01 | Defective Delivery System: Sustained trend of failure to dispense complaints. | Perrigo Company PLC / 7,775,813 metered dose inhalers | Class II | Terminated |
| D-0009-2021 | 09-16-2020 | Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01 | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-1625-2020 | 09-16-2020 | Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer shipping carton, Rx Only, Distributed by arbor Atlanta, GA, NDC 24338-200-12 | Subpotent Drug | Arbor Pharmaceuticals Inc. / 1846 cartons | Class III | Terminated |
| D-0010-2021 | 09-16-2020 | Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01 | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-0011-2021 | 09-16-2020 | Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10 | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Calvin Scott & Company, Inc. / N/A | Class II | Terminated |
| D-0040-2021 | 09-11-2020 | Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC, 20009, NDC 74625-003-04, UPC 7401037203250. | Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%. | Genesis Partnership Company SA / 5,320 bottles | Class II | Ongoing |
| D-0041-2021 | 09-11-2020 | Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC 20009, NDC 74625-003-05, UPC 7401037203427. | Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%. | Genesis Partnership Company SA / 8600 bottles | Class II | Ongoing |
| D-0037-2021 | 09-11-2020 | Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016. | CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels. | Genesis Partnership Company SA / 33,480 bottles | Class II | Ongoing |
| D-0039-2021 | 09-11-2020 | Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-04, UPC 7401037203427. | CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels. | Genesis Partnership Company SA / 5,040 bottles | Class II | Ongoing |
| D-0038-2021 | 09-11-2020 | Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773. | CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels. | Genesis Partnership Company SA / 15,000 bottles | Class II | Ongoing |
| D-0015-2021 | 09-09-2020 | Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40 | Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint | PAI Holdings, LLC. dba Pharmaceutical Associates Inc / 13480 cups | Class III | Terminated |
| D-1342-2022 | 09-09-2020 | M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC Code: 77797-001-01, Distributed by: Medek, LLC 315 E. Business Hwy 83 Alamo, TX 78516, NDC Code: 75432-001-02. | Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol. | MEDEK LLC / 256 bottles | Class I | Terminated |
| D-0004-2021 | 09-09-2020 | Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3. | Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling. | P & L Developments, LLC / 4,752 cartons | Class III | Terminated |
| D-0003-2021 | 09-04-2020 | Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21. Package NDCs: 0093-3656-40; 0093-3239-40; 0093-3657-40; 0093-3658-40; 0093-3659-40; 0093-3656-21 | Failed Stability Specifications: Below specification result for buprenorphine release rate. | Teva Pharmaceuticals USA / 32,543 cartons | Class II | Terminated |
| D-1628-2020 | 09-03-2020 | Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01 | CGMP Deviations | Akorn, Inc. / 25,843 bottles | Class II | Terminated |
| D-1586-2020 | 09-03-2020 | Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC, McLean, VA 22102, USA, Made in China. | Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded. | CORGIOMED LLC / 28900 bottles | Class I | Terminated |
| D-1620-2020 | 09-03-2020 | bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A. DE C.V. Recursos Hidraulicos No. 1 Secc. A, Col La Loma Zona Industrial, Tlalnepantla de Baz C.P. 54060 Edo. Mexico. UPC 7 502272 12108 5 | CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product. | AJR TRADING LLC / 2000 bottles | Class II | Terminated |
| D-1627-2020 | 09-02-2020 | pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, TN 37115, UPC Code: 3 49597 00044 5. | Marketed without an Approved NDA/ANDA. | pH-D Feminine Health / a. 37,000 boxes; b. 45,000 boxes; c. 6,100 boxes | Class II | Terminated |
| D-0791-2021 | 09-02-2020 | HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131 | CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits. | Charles Paint Research Inc / 3,900 gallons | Class II | Terminated |
| D-1623-2020 | 09-02-2020 | Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in a) 90-count bottles (NDC 68788-7604-09), b) 100-count tablets (NDC 68788-7604-01), Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. | CGMP Deviations | Preferred Pharmaceuticals, Inc. / N/A | Class II | Terminated |
| D-1621-2020 | 09-02-2020 | Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 100-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-9283-01 | CGMP Deviations | Preferred Pharmaceuticals, Inc. / N/A | Class II | Terminated |
| D-1622-2020 | 09-02-2020 | Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg, 90-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-6860-09 | CGMP Deviations | Preferred Pharmaceuticals, Inc. / N/A | Class II | Terminated |
| D-1624-2020 | 09-02-2020 | Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg, 90-count bottles, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-7605-09 | CGMP Deviations | Preferred Pharmaceuticals, Inc. / N/A | Class II | Terminated |
| D-0792-2021 | 09-02-2020 | HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131 | CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits. | Charles Paint Research Inc / 600 gallons | Class II | Terminated |
| D-1595-2020 | 09-01-2020 | Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling. | Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall. | The Protein Shoppe / 21,511 tablets | Class I | Terminated |
| D-1596-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38 mcg], 1 Grain (65 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3300-4; b) 60-count bottles, NDC 64727-3300-5; c) 90-count bottles, NDC 64727-3300-6; d) 100-count bottles, NDC 64727-3300-1; and e) 1,000-count bottles, NDC 64727-3300-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1612-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-6150-2 ; b) 30 Tablets, NDC 64727-6150-4; c) 60 Tablets, NDC 64727-6150-5; d) 90 Tablets, NDC 64727-6150-6; e) 100 Tablets, NDC 64727-6150-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1609-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5750-2 ; b) 30 Tablets, NDC 64727-5750-4; c) 60 Tablets, NDC 64727-5750-5; d) 90 Tablets, NDC 64727-5750-6; e) 100 Tablets, NDC 64727-5750-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1614-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 30-count bottles (NDC 64727-5550-4), b) 90-count bottles (NDC 64727-5550-6), c) 100-count bottles (NDC 64727-5550-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024 | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. / N/A | Class I | Terminated |
| D-1607-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5550-2 ; b) 30 Tablets, NDC 64727-5550-4; c) 60 Tablets, NDC 64727-5550-5; d) 90 Tablets, NDC 64727-5550-6; e) 100 Tablets, NDC 64727-5550-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1598-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg], 1/2 Grain (32.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3299-4; b) 60-count bottles, NDC 64727-3299-5; c) 90-count bottles, NDC 64727-3299-6; d) 100-count bottles, NDC 64727-3299-1; and e) 1000-count bottles, NDC 64727-3299-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1617-2020 | 08-25-2020 | Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg], 100-count bottles, Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3303-1 | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. / N/A | Class I | Terminated |
| D-1604-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 22.5 mcg and levothyroxine (T4) 95 mcg], 2.5 Grain (162.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3310-4; b) 60-count bottles, NDC 64727-3310-5; c) 90-count bottles, NDC 64727-3310-6; d) 100-count bottles, NDC 64727-3310-1; and e) 1,000-count bottles, NDC 64727-3310-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1600-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 13.5 mcg and levothyroxine (T4) 57 mcg], 1.5 Grain (97.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3305-4; b) 60-count bottles, NDC 64727-3305-5; c) 90-count bottles, NDC 64727-3305-6; d) 100-count bottles, NDC 64727-3305-1; and e) 1,000-count bottles, NDC 64727-3305-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1599-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 11.25 mcg and levothyroxine (T4) 47.5 mcg], 1.25 Grain (81.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3303-4; b) 60-count bottles, NDC 64727-3303-5; c) 90-count bottles, NDC 64727-3303-6; d) 100-count bottles, NDC 64727-3303-1; e) 1,000-count bottles, NDC 64727-3303-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1616-2020 | 08-25-2020 | Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, Levothyroxine (T4) 28.5 mcg], packaged in a) 100-count bottles (NDC 64727-3302-1) and b) 1000-count bottles (NDC 64727-3302-2), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. / N/A | Class I | Terminated |
| D-1610-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 1.25 Grain (81.25 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-6050-2 ; b) 30 Tablets, NDC 64727-6050-4; c) 60 Tablets, NDC 64727-6050-5; d) 90 Tablets, NDC 64727-6050-6; e) 100 Tablets, NDC 64727-6050-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1619-2020 | 08-25-2020 | Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg], packaged in a) 30-count bottles (NDC 64727-3305-4), b) 60-count bottles (NDC 64727-3305-5), c) 90-count bottles (NDC 64727-3305-6), and 100-count bottles (NDC 64727-3305-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3305-1 | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. / N/A | Class I | Terminated |
| D-1603-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg], 2.25 Grain (146.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3309-4; b) 60-count bottles, NDC 64727-3309-5; c) 90-count bottles, NDC 64727-3309-6; d) 100-count bottles, NDC 64727-3309-1; and e) 1,000-count bottles, NDC 64727-3309-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1615-2020 | 08-25-2020 | Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 90-count bottles (NDC 64727-3299-6), b) 100-count bottles (NDC 64727-3299-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. / N/A | Class I | Terminated |
| D-1618-2020 | 08-25-2020 | Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levothyroxine (T4) 76 mcg], packaged in a) 30-count bottles (NDC 64727-3308-4) and b)100-count bottles (NDC 64727-3308-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024 | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. / N/A | Class I | Terminated |
| D-1608-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 3/4 Grain (48.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5650-2 ; b) 30 Tablets, NDC 64727-5650-4; c) 60 Tablets, NDC 64727-5650-5; d) 90 Tablets, NDC 64727-5650-6; e) 100 Tablets, NDC 64727-5650-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-0116-2021 | 08-25-2020 | V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de Mexico. 14200 ; | Lack of CGMPs: | Asiaticon, SA de CV / 111,500 units | Class II | Terminated |
| D-1601-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg], 1.75 Grain (113.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3307-4; b) 60-count bottles, NDC 64727-3307-5; c) 90-count bottles, NDC 64727-3307-6; d) 100-count bottles, NDC 64727-3307-1; and e) 1,000-count bottles, NDC 64727-3307-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1605-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 27 mcg and levothyroxine (T4) 114 mcg], 3 Grain (195 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3312-4; b) 60-count bottles, NDC 64727-3312-5; c) 90-count bottles, NDC 64727-3312-6; d) 100-count bottles, NDC 64727-3312-1; and e) 1,000-count bottles, NDC 64727-3312-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1606-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-5450-4; b) 60-count bottles, NDC 64727-5450-5; c) 90-count bottles, NDC 64727-5450-6; d) 100-count bottles, NDC 64727-5450-1; and e) 1,000-count bottles, NDC 64727-5450-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1602-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 18 mcg and levothyroxine (T4) 76 mcg], 2 Grain (130 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3308-4; b) 60-count bottles, NDC 64727-3308-5; c) 90-count bottles, NDC 64727-3308-6; d) 100-count bottles, NDC 64727-3308-1; and e) 1,000-count bottles, NDC 64727-3308-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-0117-2021 | 08-25-2020 | Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI 53105 Made in Mexico by Asiaticon S.A. de C.V. Conkal No. 62, Mexico, Ciudad de Mexico 14200, Mexico NDC: 75192-600-02 UPC 7 503019 005002 | Lack of CGMPs: | Asiaticon, SA de CV / 111,500 units | Class II | Terminated |
| D-1611-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5850-2 ; b) 30 Tablets, NDC 64727-5850-4; c) 60 Tablets, NDC 64727-5850-5; d) 90 Tablets, NDC 64727-5850-6; e) 100 Tablets, NDC 64727-5850-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034 | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1597-2020 | 08-25-2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 6.75 mcg and levothyroxine (T4) 28.5 mcg], 3/4 Grain (48.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3302-4; b) 60-count bottles, NDC 64727-3302-5; c) 90-count bottles, NDC 64727-3302-6; d) 100-count bottles, NDC 64727-3302-1; and e) 1,000-count bottles, NDC 64727-3302-2; Rx Only, Manufactured by: RLC Labs Phoenix, AZ 85034. | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-1613-2020 | 08-25-2020 | WP Thyroid, Westhroid Pure, 2 Grain (130 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5950-2 ; b) 30 Tablets, NDC 64727-5950-4; c) 60 Tablets, NDC 64727-5950-5; d) 90 Tablets, NDC 64727-5950-6; e) 100 Tablets, NDC 64727-5950-1; Rx Only, Manufactured by: RLC Labs Phoenix, AZ 85034 | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. / N/A | Class II | Terminated |
| D-0001-2021 | 08-24-2020 | Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brunswick NJ 08816 NDC 64380-860-06 Package NDCs: 64380-860-06; 64380-860-07; 64380-860-08; 64380-861-06; 64380-861-07; 64380-861-08 | Failed Dissolution Specifications | Strides Inc. / 11,280 bottles | Class II | Terminated |
| D-0013-2021 | 08-24-2020 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. Package NDCs: 0093-3145-01; 0093-3145-05; 0093-3147-01; 0093-3147-05; 0093-4175-73; 0093-4175-74; 0093-4177-73; 0093-4177-74 | CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits. | Teva Pharmaceuticals USA / 1,467,535 bottles | Class II | Terminated |
| D-1566-2020 | 08-24-2020 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73. Package NDCs: 0093-3145-01; 0093-3145-05; 0093-3147-01; 0093-3147-05; 0093-4175-73; 0093-4175-74; 0093-4177-73; 0093-4177-74 | Sub-Potent Drug: Out of specification test results for potency (below specification). | Teva Pharmaceuticals USA / 38,487 bottles | Class II | Terminated |
| D-0012-2021 | 08-24-2020 | Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. Package NDCs: 0093-3145-01; 0093-3145-05; 0093-3147-01; 0093-3147-05; 0093-4175-73; 0093-4175-74; 0093-4177-73; 0093-4177-74 | CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits. | Teva Pharmaceuticals USA / 103,940 bottles | Class II | Terminated |
| D-1544-2020 | 08-19-2020 | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01 Package NDCs: 76385-128-10; 76385-128-01; 76385-128-50; 76385-129-01; 76385-129-50 | CGMP Deviations | BAYSHORE PHARMACEUTICALS / 3984 bottles | Class II | Terminated |
| D-1543-2020 | 08-19-2020 | Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10 Package NDCs: 76385-128-10; 76385-128-01; 76385-128-50; 76385-129-01; 76385-129-50 | CGMP Deviations | BAYSHORE PHARMACEUTICALS / 594 bottles | Class II | Terminated |
| D-1591-2020 | 08-18-2020 | Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy Ste 100 McAllen, TX USA 78503, NDC# 76562-000-85, UPC 6 64213 64350 0 | cGMP Deviations | GRUPO YACANA MEXICO SAS DE CV / 43,728 bottles | Class II | Terminated |
| D-1593-2020 | 08-18-2020 | Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V. NDC 69912-006-01 | GMP Deviations: Potential to contain 1-propanol. | Nanomateriales Sa De Cv / 1,000 kg | Class II | Terminated |
| D-1592-2020 | 08-18-2020 | Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 531151); b) 1 gal (3.76L) (NDC 69912-008-02 UPC 2 000000 531144) bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V. | GMP Deviations: Potential to contain 1-propanol. | Nanomateriales Sa De Cv / a)19,440 liters b) 25,917 gallon | Class II | Terminated |
| D-1590-2020 | 08-18-2020 | Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Grupo Yacana Mexico SAS de CV Ave. Alfonso reyes 714 Col. Contry La Silla, Monterrey, Nuevo Leon, Mexico Tel. +52 812473-8453, NDC # 76592-002-04, UPC 6 03765 37699 3 | cGMP Deviations | GRUPO YACANA MEXICO SAS DE CV / 55,560 bottles | Class II | Terminated |
| D-1584-2020 | 08-17-2020 | Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural Products, www.maisonterre.net | Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others. | Maison Terre, LLC / 670 bags | Class I | Terminated |
| D-1575-2020 | 08-17-2020 | Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103. Package NDCs: 67457-153-00; 67457-153-03; 67457-153-99; 67457-153-09; 67457-153-18 | Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. | Mylan Institutional LLC / 13,682 cartons | Class I | Terminated |
| D-1576-2020 | 08-17-2020 | Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103. Package NDCs: 67457-197-00; 67457-197-10 | Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. | Mylan Institutional LLC / 1407 cartons | Class I | Terminated |
| D-1533-2020 | 08-14-2020 | Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01. Package NDCs: 0143-9246-01; 0143-9246-05 | Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. | Hikma Pharmaceuticals USA Inc. / 97,890 vials | Class II | Terminated |
| D-0033-2021 | 08-14-2020 | Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/ 16 fl oz bottle, Vou-Sol 5095 W 2100 S, Salt Lake City, UT 84120, NDC 74401-800-16 | Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label. | Volu-Sol, Inc. / N/A | Class I | Terminated |
| D-0795-2021 | 08-14-2020 | Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO. | Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content. | Grupo Asimex de Mexico SA de CV / 22,680 bottles | Class I | Terminated |
| D-0796-2021 | 08-14-2020 | Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO. | CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol. | Grupo Asimex de Mexico SA de CV / N/A | Class II | Terminated |
| D-1572-2020 | 08-14-2020 | SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147125 | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug | SG24 LLC / 9600 bottles | Class I | Terminated |
