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-0780-2021 | 05-12-2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00420 8, | Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol. | Global Sanitizers LLC / 50,000 bottles | Class I | Ongoing |
| D-0782-2021 | 05-12-2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 , | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol. | Global Sanitizers LLC / N/A | Class II | Ongoing |
| D-0779-2021 | 05-12-2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC 6 76753 00414 7 | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol. | Global Sanitizers LLC / 50,000 bottles | Class II | Ongoing |
| D-0778-2021 | 05-12-2021 | MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00417 8 | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol. | Global Sanitizers LLC / 50,000 bottles | Class II | Ongoing |
| D-0781-2021 | 05-12-2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 | Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol. | Global Sanitizers LLC / N/A | Class I | Ongoing |
| D-0645-2021 | 05-11-2021 | DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.1 mL) bottle, NDC 73009-001-16, UPC 8 53090 00302 0 and b) 8 FL OZ (236.5 mL) bottle, NDC 73009-0001-08, UPC 8 53090 00301 3; Distributed by: S.E.N.D, LLC., Anthony, NM 88021; Imported by: Dibar Labs, LLC., Sugar Land, TX 77479, Made in Mexico. | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol. | DIBAR NUTRICIONAL S DE RL DE CV / Unknown quantity | Class II | Terminated |
| D-0646-2021 | 05-11-2021 | ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-002-02 bottles, Imported by: Dibar Labs, LLC., Sugar Land, TX 77479; Distributed by: PR Trading LLC, PO Box 19647, San Juan, PR 00910, Made in Mexico. | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol. | DIBAR NUTRICIONAL S DE RL DE CV / Unknown quantity | Class II | Terminated |
| D-0644-2021 | 05-11-2021 | DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Imported by Dibar Labs, LLC, Sugar Land, TX 77479, Made in Mexico,77479, NDC 73009-0001-08 UPC 8 53090 00301 3. | Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol. | DIBAR NUTRICIONAL S DE RL DE CV / Unknown quantity | Class I | Terminated |
| D-0647-2021 | 05-11-2021 | ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Distributed by: Lifetime Health Services, Pharr, TX 78577, Made in Mexico, NDC; 79284-005-00. UPC 8 60004 06470 1 | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol. | DIBAR NUTRICIONAL S DE RL DE CV / Unknown quantity | Class II | Terminated |
| D-0718-2021 | 05-11-2021 | C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117 | Non-Sterility | People's Custom Rx and Clinical Care, LLC / 14 vials | Class I | Terminated |
| D-0654-2021 | 05-11-2021 | Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0 | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall. | Yamtun7 / 36 capsules | Class I | Terminated |
| D-0628-2021 | 05-11-2021 | Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg | Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine | DASH XCLUSIVE / 25 pieces (boxes containing 15 sachets) | Class II | Ongoing |
| D-0391-2021 | 05-07-2021 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96 Package NDCs: 47335-506-96; 47335-507-97 | Subpotent and Presence of Particulates . | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class III | Terminated |
| D-0602-2021 | 05-05-2021 | BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10 Package NDCs: 69584-091-10; 69584-091-50; 69584-092-10; 69584-092-50; 69584-093-06; 69584-093-10; 69584-093-50; 69584-094-06; 69584-094-18; 69584-094-50 | Presence of Foreign Tablets/Capsules | Oxford Pharmaceuticals, LLC / 6,864 bottles | Class II | Completed |
| D-0372-2021 | 05-04-2021 | Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02. Package NDCs: 62756-142-01; 62756-142-02; 62756-143-01 | Presence of foreign substance: identified as activated carbon. | SUN PHARMACEUTICAL INDUSTRIES INC / 50868 bottles | Class II | Terminated |
| D-0600-2021 | 05-04-2021 | Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 | Subpotent Drug | Boehringer Ingelheim Pharmaceuticals, Inc. / 15,198 bottles (30 tablets per bottle) | Class II | Terminated |
| D-0599-2021 | 05-04-2021 | Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05. Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10 | Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities | Dr. Reddy's Laboratories, Inc. / 2980 500 count -bottles | Class III | Terminated |
| D-0626-2021 | 05-03-2021 | 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. Package NDCs: 0409-1159-18; 0409-1159-01; 0409-1159-19; 0409-1159-02; 0409-1160-18; 0409-1160-01; 0409-1162-18; 0409-1162-01; 0409-1162-19; 0409-1162-02; 0409-1163-18; 0409-1163-01; 0409-1165-18; 0409-1165-01; 0409-1165-19; 0409-1165-02; 0409-9043-11; 0409-9043-01; 0409-9046-11; 0409-9046-01; 0409-9045-11; 0409-9045-01; 0409-9045-16; 0409-9045-17; 0409-9042-11; 0409-9042-01; 0409-9042-16; 0409-9042-17 | Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP | PFIZER, INC / 163,957 vials | Class I | Terminated |
| D-0384-2021 | 05-03-2021 | Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25 Package NDCs: 0409-4887-25; 0409-4887-99; 0409-4887-31; 0409-4887-05; 0409-4887-17; 0409-4887-10; 0409-4887-32; 0409-4887-34; 0409-4887-23; 0409-4887-20; 0409-4887-24; 0409-4887-50 | Presence of Particulate Matter: particulate matter identified as an insect in one vial. | Pfizer Inc. / 49,525 vials | Class II | Terminated |
| D-0627-2021 | 05-03-2021 | 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. Package NDCs: 0409-4713-12; 0409-4713-26; 0409-4713-02; 0409-4713-72; 0409-4713-62; 0409-4713-75; 0409-4713-65; 0409-4713-42; 0409-4713-25; 0409-4713-32; 0409-4278-16; 0409-4278-01; 0409-4279-16; 0409-4279-02; 0409-4776-10; 0409-4776-01; 0409-4282-11; 0409-4282-25; 0409-4282-01; 0409-4282-12; 0409-4282-02; 0409-4277-16; 0409-4277-01; 0409-4277-17; 0409-4277-02; 0409-4276-16; 0409-4276-01; 0409-4276-17; 0409-4276-02; 0409-4275-16; 0409-4275-01 | Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP | PFIZER, INC / 139,050 vials | Class I | Terminated |
| D-0601-2021 | 05-03-2021 | Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institutional, Galway, Ireland. NDC: 67457-196-02 Package NDCs: 67457-196-00; 67457-196-02 | Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901. | Mylan Institutional LLC / 2,131 cartons | Class III | Terminated |
| D-0396-2021 | 04-29-2021 | NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count bottles (NDC 42192-329-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 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; 42192-329-07 | Subpotent Drug | Acella Pharmaceuticals, LLC / a) 113,019 bottles; b) 44,900 bottles | Class I | Terminated |
| D-0397-2021 | 04-29-2021 | NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-330-01 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 | Acella Pharmaceuticals, LLC / 154,726 bottles | Class I | Terminated |
| D-0395-2021 | 04-29-2021 | NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 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; 42192-327-07 | Subpotent Drug | Acella Pharmaceuticals, LLC / a) 66,155 bottles; b) 26,212 bottles | Class I | Terminated |
| D-0399-2021 | 04-29-2021 | NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192-328-07) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 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; 42192-328-07 | Subpotent Drug | Acella Pharmaceuticals, LLC / a) 69,289 bottles; b) 9,076 bottles | Class I | Terminated |
| D-0398-2021 | 04-29-2021 | NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-331-01 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 | Acella Pharmaceuticals, LLC / 79,344 bottles | Class I | Terminated |
| D-0392-2021 | 04-29-2021 | Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30. Package NDCs: 67877-445-30; 67877-445-90; 67877-445-05; 67877-445-10; 67877-446-30; 67877-446-90; 67877-446-05; 67877-446-10; 67877-446-33; 67877-446-84; 67877-446-74; 67877-446-38; 67877-447-30; 67877-447-90; 67877-447-05; 67877-447-10 | Presence of Foreign Tablet/Capsule | Ascend Laboratories LLC / 34296 bottles | Class III | Terminated |
| D-0390-2021 | 04-29-2021 | Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01 Package NDCs: 68180-405-01; 68180-407-03; 68180-407-04; 68180-416-08; 68180-416-11; 68180-423-11; 68180-423-08 | Subpotent Drug | Lupin Pharmaceuticals Inc. / 3,138 bottles | Class II | Terminated |
| D-0607-2021 | 04-28-2021 | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92 Package NDCs: 49230-206-92; 49230-206-94; 49230-206-95; 49230-209-92; 49230-209-94; 49230-209-95; 49230-212-92; 49230-212-94; 49230-212-95 | Temperature Abuse: Product exposed to temperature outside specified limits. | Fresenius Medical Care Holdings, Inc. / 5 cases | Class III | Terminated |
| D-0609-2021 | 04-28-2021 | DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92 Package NDCs: 49230-206-92; 49230-206-94; 49230-206-95; 49230-209-92; 49230-209-94; 49230-209-95; 49230-212-92; 49230-212-94; 49230-212-95 | Temperature Abuse: Product exposed to temperature outside specified limits. | Fresenius Medical Care Holdings, Inc. / 4 cases | Class III | Terminated |
| D-0610-2021 | 04-28-2021 | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451 Package NDCs: 49230-206-20; 49230-206-30; 49230-206-32; 49230-206-50; 49230-206-60; 49230-206-62; 49230-206-52; 49230-209-23; 49230-209-30; 49230-209-32; 49230-209-50; 49230-209-60; 49230-209-62; 49230-209-52; 49230-212-23; 49230-212-30; 49230-212-32; 49230-212-50; 49230-212-60; 49230-212-62; 49230-212-52 | Temperature Abuse: Product exposed to temperature outside specified limits. | Fresenius Medical Care Holdings, Inc. / 285 cases | Class III | Terminated |
| D-0608-2021 | 04-28-2021 | DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451, Package NDCs: 49230-206-92; 49230-206-94; 49230-206-95; 49230-209-92; 49230-209-94; 49230-209-95; 49230-212-92; 49230-212-94; 49230-212-95 | Temperature Abuse: Product exposed to temperature outside specified limits. | Fresenius Medical Care Holdings, Inc. / 39 cases | Class III | Terminated |
| D-0605-2021 | 04-28-2021 | DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451 Package NDCs: 49230-206-20; 49230-206-30; 49230-206-32; 49230-206-50; 49230-206-60; 49230-206-62; 49230-206-52; 49230-209-23; 49230-209-30; 49230-209-32; 49230-209-50; 49230-209-60; 49230-209-62; 49230-209-52; 49230-212-23; 49230-212-30; 49230-212-32; 49230-212-50; 49230-212-60; 49230-212-62; 49230-212-52; 49230-0209-23 | Temperature Abuse: Product exposed to temperature outside specified limits. | Fresenius Medical Care Holdings, Inc. / 672 cases | Class III | Terminated |
| D-0385-2021 | 04-28-2021 | Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1 | CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day. | Preferred Pharmaceuticals, Inc. / 147 bottles (14,700 extended release tablets) | Class II | Ongoing |
| D-0604-2021 | 04-28-2021 | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50 | Temperature Abuse: Product exposed to temperature outside specified limits. | Fresenius Medical Care Holdings, Inc. / 25 cases | Class III | Terminated |
| D-0606-2021 | 04-28-2021 | DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50 | Temperature Abuse: Product exposed to temperature outside specified limits. | Fresenius Medical Care Holdings, Inc. / 49 cases | Class III | Terminated |
| D-0603-2021 | 04-28-2021 | Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10 | Temperature Abuse: Product exposed to temperature outside specified limits. | Fresenius Medical Care Holdings, Inc. / 48 cases | Class II | Terminated |
| D-0679-2021 | 04-27-2021 | Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02424 0 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 1,260 bottles | Class I | Terminated |
| D-0666-2021 | 04-27-2021 | Ulta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray, Net Wt. 100.55/3.4 fl. oz., UPC 717897092017 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 12,976 bottles | Class I | Terminated |
| D-0672-2021 | 04-27-2021 | Goose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 14630 02049 5 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 1,296 bottles | Class I | Terminated |
| D-0680-2021 | 04-27-2021 | Goose Creek Hand Sanitizer aloe Optimistic Vibes, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02234 5 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 1,296 bottles | Class I | Terminated |
| D-0669-2021 | 04-27-2021 | SS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / a) 5,112 bottles; b) 4,968 bottles | Class I | Terminated |
| D-0671-2021 | 04-27-2021 | SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / a) 4,788 bottles; b) 3,168 bottles | Class I | Terminated |
| D-0678-2021 | 04-27-2021 | Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01331 8 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 1,296 bottles | Class I | Terminated |
| D-0682-2021 | 04-27-2021 | Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 814630 02423 3 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 1,296 bottles | Class I | Terminated |
| D-0673-2021 | 04-27-2021 | Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL),Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 18489 01333 2 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 1,296 bottles | Class I | Terminated |
| D-0683-2021 | 04-27-2021 | Goose Creek Hand Sanitizer aloe Tropical Daydream, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01335 6 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 1,260 bottles | Class I | Terminated |
| D-0667-2021 | 04-27-2021 | SS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Black and White Collection; b) Photo Real Collection | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / a) 2,952 bottles; b) 2,988 bottles | Class I | Terminated |
| D-0676-2021 | 04-27-2021 | Goose Creek Hand Sanitizer aloe Champagne Bubbles, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01334 9 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 1,296 bottles | Class I | Terminated |
| D-0668-2021 | 04-27-2021 | SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Black and White Collection; b) Photo Real Collection | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / a) 4,248 bottles; b) 3,960 bottles | Class I | Terminated |
| D-0675-2021 | 04-27-2021 | Goose Creek Hand Sanitizer aloe Grape Soda, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01328 8 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 1,296 bottles | Class I | Terminated |
| D-0674-2021 | 04-27-2021 | Goose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandles.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 18489 01336 3 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 1,296 bottles | Class I | Terminated |
| D-0681-2021 | 04-27-2021 | Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02045 7 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 1,512 bottles | Class I | Terminated |
| D-0684-2021 | 04-27-2021 | Coconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4 FL. OZ. (100.55 mL), Distributed by: Beauty Sparks LLC St. Petersburg, FL 33711 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 500 bottles | Class I | Terminated |
| D-0677-2021 | 04-27-2021 | Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01332 5 | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / 1,296 bottles | Class I | Terminated |
| D-0670-2021 | 04-27-2021 | SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. | Scentsational Soaps & Candles Inc / a) 4,680 bottles; b) 4,968 bottles | Class I | Terminated |
| D-0386-2021 | 04-27-2021 | Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03 Package NDCs: 10702-055-03; 10702-055-09; 10702-055-01; 10702-055-10 | Failed Impurities/Degradation Specifications | KVK-Tech, Inc. / 17,096 bottles | Class III | Terminated |
| D-0377-2021 | 04-26-2021 | Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04 Package NDCs: 0703-4502-01; 0703-4502-04 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 3,138/25 single use vials per tray | Class II | Terminated |
| D-0374-2021 | 04-26-2021 | Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-5145-91 (Novaplus, a registered trademark of Vizient, Inc.) | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 192,277 cartons/1 single dose vial per carton | Class II | Terminated |
| D-0375-2021 | 04-26-2021 | Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 3150 vials | Class II | Terminated |
| D-0378-2021 | 04-26-2021 | Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 7020 vials | Class II | Terminated |
| D-0376-2021 | 04-26-2021 | Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 7,564/1 multiple dose vial per carton | Class II | Terminated |
| D-0367-2021 | 04-21-2021 | Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-01. Packaged in 150 cc white HDPE bottle Package NDCs: 23155-227-01; 23155-227-05; 23155-228-01; 23155-228-05 | Labeling: Incorrect or Missing Lot and/or Exp Date | Heritage Pharmaceuticals Inc / 408 bottles | Class III | Terminated |
| D-0357-2021 | 04-20-2021 | Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50242-175-05 | Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes. | Genentech Inc / 2,627 bottles | Class III | Terminated |
| D-0373-2021 | 04-20-2021 | BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-38 Package NDCs: 54365-400-38 | Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution. | CareFusion 213, LLC / 707,050 eaches | Class I | Terminated |
| D-0380-2021 | 04-19-2021 | Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10 Package NDCs: 42794-016-22; 42794-016-08; 42794-016-10; 42794-017-22; 42794-017-08; 42794-017-10 | Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent | SigmaPharm Laboratories LLC / 8786 bottles | Class III | Terminated |
| D-0379-2021 | 04-19-2021 | Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10. Package NDCs: 42794-016-22; 42794-016-08; 42794-016-10; 42794-017-22; 42794-017-08; 42794-017-10 | Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent | SigmaPharm Laboratories LLC / 6266 bottles | Class III | Terminated |
| D-0336-2021 | 04-16-2021 | Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8 Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8 | Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals Inc / 12060 cartons | Class II | Terminated |
| D-0337-2021 | 04-16-2021 | Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8 Package NDCs: 68968-3425-8; 68968-3437-8; 68968-3450-8; 68968-3475-8; 68968-3410-8 | Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals Inc / 10872 cartons | Class II | Terminated |
| D-0355-2021 | 04-15-2021 | Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Gas Cylinder; d) E Medical Gas Cylinder; e) M Medical Gas Cylinder; f) H Medical Gas Cylinder, Rx only, Grace Healthcare 1418 31st Avenue Gulfport, MS 39501 228-863-3331 | cGMP deviations | Grace Healthcare Medical, Inc / 35,838 cylinders | Class II | Terminated |
| D-0389-2021 | 04-14-2021 | Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451 Package NDCs: 49230-206-20; 49230-206-30; 49230-206-32; 49230-206-50; 49230-206-60; 49230-206-62; 49230-206-52; 49230-209-23; 49230-209-30; 49230-209-32; 49230-209-50; 49230-209-60; 49230-209-62; 49230-209-52; 49230-212-23; 49230-212-30; 49230-212-32; 49230-212-50; 49230-212-60; 49230-212-62; 49230-212-52 | Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box. | Fresenius Medical Care, North America / 709 cases | Class II | Terminated |
| D-0387-2021 | 04-13-2021 | Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manufactured by: Nomax, Inc, St. Louis, MO 63123, NDC: 51801-008-15 Package NDCs: 51801-008-15 | Subpotent Drug | Nomax Inc / 78 cartons | Class III | Terminated |
| D-0335-2021 | 04-12-2021 | Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178 | Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility | Edge Pharma, LLC / 5850 syringes | Class II | Terminated |
| D-0342-2021 | 04-12-2021 | Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Preferred Pharmaceuticals, Inc., Mfg: Ascend Laboratories, LLC, NDC #: 68788-7529-1, Package NDCs: 68788-7529-1; 68788-7529-2 | Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin | Preferred Pharmaceuticals, Inc. / Six bottles | Class II | Ongoing |
| D-0356-2021 | 04-09-2021 | Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60 | Failed Impurities/Degradation Specifications: | Teligent Pharma, Inc. / 3432 tubes | Class II | Ongoing |
| D-0641-2021 | 04-08-2021 | Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil | NSNY Distributor Inc / 2600 capsules | Class I | Ongoing |
| D-0642-2021 | 04-08-2021 | Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil | NSNY Distributor Inc / 399 capsules | Class I | Ongoing |
| D-0382-2021 | 04-06-2021 | PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. | Hyobin LLC / 500 cards | Class II | Ongoing |
| D-0381-2021 | 04-06-2021 | PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. | Hyobin LLC / 500 cards | Class II | Ongoing |
| D-0383-2021 | 04-06-2021 | Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. | Hyobin LLC / 300 cards | Class II | Ongoing |
| D-0333-2021 | 04-01-2021 | Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30. | Failed Dissolution Specifications | Jubilant Cadista Pharmaceuticals, Inc. / Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles) | Class II | Terminated |
| D-0371-2021 | 03-31-2021 | Imperial Platinum 2000, 1 capsule, UPC 718122040702 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | QMart / 200 boxes | Class II | Ongoing |
| D-0370-2021 | 03-31-2021 | Burro en Primavera, 2 capsules, UPC 638632431055 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | QMart / 500 boxes | Class II | Ongoing |
| D-0369-2021 | 03-31-2021 | PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | QMart / 500 boxes | Class II | Ongoing |
| D-0368-2021 | 03-31-2021 | IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | QMart / 200 boxes | Class II | Ongoing |
| D-0334-2021 | 03-31-2021 | Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 10631-206-02. Package NDCs: 10631-238-01; 10631-238-02; 10631-206-01; 10631-206-02 | Microbial Contamination of Non-Sterile Product | SUN PHARMACEUTICAL INDUSTRIES INC / 13,834 bottles | Class II | Terminated |
| D-0324-2021 | 03-31-2021 | Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0 Package NDCs: 60505-3927-3; 60505-3927-1; 60505-3927-8; 60505-3928-3; 60505-3928-1; 60505-3928-8; 60505-3929-3; 60505-3929-1; 60505-3929-8; 60505-3930-3; 60505-3930-1; 60505-3930-8 | Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate | Apotex Corp. / 55620 bottles | Class II | Ongoing |
| D-0353-2021 | 03-30-2021 | PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | Na Na Collection / N/A | Class II | Ongoing |
| D-0662-2021 | 03-30-2021 | Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860 | Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall. | Ummzy, LLC / N/A | Class I | Terminated |
| D-0354-2021 | 03-30-2021 | Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule per box, Distributed by VIEW LIFE Distributors Los Angeles CA 90005 UPC 7 15122 05089 4 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. | Na Na Collection / N/A | Class II | Ongoing |
| D-0663-2021 | 03-30-2021 | Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185 | Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall. | Ummzy, LLC / 364 boxes/10 capsules per box | Class I | Terminated |
| D-0664-2021 | 03-30-2021 | Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680. | Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall. | Ummzy, LLC / 163 boxes/10 capsules per box | Class I | Terminated |
| D-0364-2021 | 03-29-2021 | Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26283 0 NDC: 64009-335-82 Package NDCs: 64009-335-85; 64009-335-82 | CGMP Deviations | Spartan Chemical Co Inc / 960 containers | Class II | Terminated |
| D-0685-2021 | 03-29-2021 | Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC | Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall. | Nuri Trading LLC / N/A | Class I | Ongoing |
| D-0686-2021 | 03-29-2021 | Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC | Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug making this an unapproved drug for which the safety and efficacy has not been established and therefore subject to recall. | Nuri Trading LLC / N/A | Class I | Ongoing |
| D-0687-2021 | 03-29-2021 | Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC | Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and vardenafil, FDA approved drugs making them an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall. | Nuri Trading LLC / N/A | Class I | Ongoing |
| D-0688-2021 | 03-29-2021 | 69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC | Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making it an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall. | Nuri Trading LLC / N/A | Class I | Ongoing |
| D-0360-2021 | 03-29-2021 | foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 42.27 oz/1250 ml per foam pump cartridge, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26454 4 NDC: 64009-202-06 | CGMP Deviations | Spartan Chemical Co Inc / 26,328 cartridges | Class II | Terminated |
| D-0359-2021 | 03-29-2021 | Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26288 5 SKU# 333806 NDC: 64009-331-82 | Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans | Spartan Chemical Co Inc / 19,044 containers | Class I | Terminated |
| D-0331-2021 | 03-29-2021 | Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14. | Failed Stability Specifications: product did not meet viscosity results. | Teligent Pharma, Inc. / 62,040 tubes | Class III | Terminated |
