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-0286-2019 | 11-06-2018 | AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan, encapsulated in the United States. NDC 64764-080-60 Package NDCs: 64764-080-60; 64764-080-40; 64764-240-60; 64764-240-10; 64764-240-40 | Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing. | Takeda Development Center Americas, Inc. / 69,075 60-count bottles (4,144,500 capsules) | Class III | Terminated |
| D-0250-2019 | 11-05-2018 | puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0. | Non-Sterility: Product manufactured under non-sterile production conditions. | Kadesh International / 18,521 bottles | Class I | Terminated |
| D-0260-2019 | 11-02-2018 | Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00 | Cross Contamination with Other Products | Sandoz Inc / 5100 bottles | Class II | Terminated |
| D-0259-2019 | 11-02-2018 | Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00 | Cross Contamination with Other Products | Sandoz Inc / 7817 bottles | Class II | Terminated |
| D-0261-2019 | 11-02-2018 | Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00 | Cross Contamination with Other Products | Sandoz Inc / 1550 bottles | Class II | Terminated |
| D-0263-2019 | 11-02-2018 | IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. | Golden State Medical Supply Inc. / 2,439 bottles | Class II | Terminated |
| D-0386-2019 | 11-02-2018 | Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc w/ needle, 25 ga x5/8 , 2 Vials of epinephrine, 1mg/1mL, 4 Alcohol prep pads, 2 Adhesive bandages, 1 x 3 1 Epi Generic Injection. Rx Only. Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016 | Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg. | Bound Tree Medical, LLC / 339 kits (1 standard syringe / 1 IFU per kit) | Class II | Terminated |
| D-0265-2019 | 11-02-2018 | IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. | Golden State Medical Supply Inc. / 12,502 bottles | Class II | Terminated |
| D-0264-2019 | 11-02-2018 | IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. | Golden State Medical Supply Inc. / 15,917 bottles | Class II | Terminated |
| D-0385-2019 | 11-02-2018 | Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016 | Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg. | Bound Tree Medical, LLC / 2,654 kits (6 syringes per kit / 1 IFU per kit) | Class II | Terminated |
| D-0383-2019 | 11-02-2018 | curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 1 Epi Safe Training Kit (8600-01102), Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016 | Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg. | Bound Tree Medical, LLC / 1,283 kits (8 syringes per kit / 3 IFU's per kit) | Class II | Terminated |
| D-0384-2019 | 11-02-2018 | curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcohol Prep Pads " 1 Adhesive Dressing " 1 Insert, Rx Only. Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016 | Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg. | Bound Tree Medical, LLC / 7,063 kits (1 syringe per kit / 1 IFU per kit) | Class II | Terminated |
| D-0258-2019 | 11-02-2018 | Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01 Package NDCs: 0781-1635-10; 0781-1635-01; 0781-1635-13; 0781-1556-01; 0781-1556-05; 0781-1556-10; 0781-1556-13; 0781-1695-13; 0781-1695-10; 0781-1695-01 | Cross Contamination with Other Products | Sandoz Inc / 18,832 bottles | Class II | Terminated |
| D-0257-2019 | 11-02-2018 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540 Package NDCs: 0185-0122-01; 0185-0122-10 | Cross Contamination with Other Products | Sandoz Inc / 14366 bottles | Class III | Terminated |
| D-0262-2019 | 11-02-2018 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01 | Cross Contamination with Other Products | Sandoz Inc / 23053 bottles | Class III | Terminated |
| D-0359-2019 | 11-01-2018 | Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. | Sandoz, Inc / 170 HDPE bottles | Class II | Ongoing |
| D-0379-2019 | 11-01-2018 | Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety needle, 2 Alcohol Prep Pads,1 Adhesive Dressing, 1 Insert. Distributed by Sarnova, HC. LLC's family companies: Bound Tree Medical. LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-amin Health Services, Inc. 5000 Tuttle Crossing Blvd, Dublin, OH 43016. Model 8600-01101 | Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May 2019. In addition, device component (syringe) lacks 510(k) clearance. | Bound Tree Medical, LLC / 747 kits | Class III | Terminated |
| D-0371-2019 | 11-01-2018 | curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administration Kit (8600-01101) and 1 Epi Safe Training Kit (8600-01102), Rx Only. Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Producs, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd, Dublin, OH 43016 | Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on December 2018, but the outer kit label has an expiration date of January 2020. In addition, device component (syringe) may lack 510(k) clearance. | Bound Tree Medical, LLC / 84 kits | Class II | Terminated |
| D-0224-2019 | 10-31-2018 | BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix, AZ 85085. NDC 42852-001-24 | Lack of Assurance of Sterility | Avella of Deer Valley, Inc. Store 38 / 911 syringes | Class II | Terminated |
| D-0300-2019 | 10-29-2018 | Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-119-01; b) 90 count bottle NDC 69367-119-03 | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan. | Westminster Pharmaceuticals Llc / 1571 bottles | Class II | Terminated |
| D-0301-2019 | 10-29-2018 | Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-120-01; b) 90 count bottle NDC 69367-120-03 | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan. | Westminster Pharmaceuticals Llc / 2319 bottles | Class II | Terminated |
| D-0302-2019 | 10-29-2018 | Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-121-01; b) 90 count bottle NDC 69367-121-03 | CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan. | Westminster Pharmaceuticals Llc / 3976 bottles | Class II | Terminated |
| D-0267-2019 | 10-29-2018 | Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Sciegen Pharmaceuticals Inc / 2,977 HDPE bottles | Class II | Terminated |
| D-0270-2019 | 10-29-2018 | GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Sciegen Pharmaceuticals Inc / 3,835 HDPE bottles | Class II | Terminated |
| D-0272-2019 | 10-29-2018 | GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Sciegen Pharmaceuticals Inc / 30,194 HDPE bottles | Class II | Terminated |
| D-0269-2019 | 10-29-2018 | Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Sciegen Pharmaceuticals Inc / 5,989 HDPE | Class II | Terminated |
| D-1208-2019 | 10-29-2018 | Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60 | Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities | Akorn, Inc. / 58,393 jars | Class III | Terminated |
| D-0271-2019 | 10-29-2018 | GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Sciegen Pharmaceuticals Inc / 18,760 HDPE bottles | Class II | Terminated |
| D-0268-2019 | 10-29-2018 | Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854, Made in the USA. | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. | Sciegen Pharmaceuticals Inc / 5,061 HDPE bottles | Class II | Terminated |
| D-0319-2019 | 10-29-2018 | Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.; Manufactured by GE Healthcare AS, Oslo, Norway; NDC 0407-1411-20. Package NDCs: 0407-1401-52; 0407-1411-10; 0407-1411-20; 0407-1412-10; 0407-1412-20; 0407-1412-50; 0407-1412-29; 0407-1412-30; 0407-1412-60; 0407-1412-33; 0407-1412-27; 0407-1412-49; 0407-1412-34; 0407-1412-28; 0407-1412-35; 0407-1413-11; 0407-1413-10; 0407-1413-59; 0407-1413-30; 0407-1413-50; 0407-1413-51; 0407-1413-61; 0407-1413-95; 0407-1413-98; 0407-1413-62; 0407-1413-99; 0407-1413-60; 0407-1413-63; 0407-1413-91; 0407-1413-53; 0407-1413-90; 0407-1413-65; 0407-1413-92; 0407-1413-66; 0407-1413-93; 0407-1413-96; 0407-1413-69; 0407-1414-21; 0407-1414-50; 0407-1414-51; 0407-1414-52; 0407-1414-89; 0407-1414-20; 0407-1414-90; 0407-1414-22; 0407-1414-53; 0407-1414-60; 0407-1414-91; 0407-1414-76; 0407-1414-03; 0407-1414-23; 0407-1414-93; 0407-1414-04; 0407-1414-94; 0407-1414-24; 0407-1414-80; 0407-1414-95; 0407-1415-09; 0407-1416-12 | Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles. | GE Healthcare Inc. Life Sciences / 1092 cartons | Class II | Terminated |
| D-0485-2019 | 10-26-2018 | Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 UPC 343598637525 ---- NDC 43598-637-52 Package NDCs: 43598-635-52; 43598-635-10; 43598-636-52; 43598-636-10; 43598-637-52; 43598-637-10; 3435986375 | Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL). | Dr. Reddy's Laboratories, Inc. / 2770 bags; 277 selling units | Class I | Terminated |
| D-0220-2019 | 10-26-2018 | deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27. Package NDCs: 11084-010-40; 11084-010-27; 11084-010-12; 11084-010-20; 11084-010-05; 11084-010-01; 11084-010-55; 11084-010-96; 11084-010-66 | CGMP Deviations: Product was released to market prior to microbiological testing. | S.C. Johnson Professional / 869 cases | Class II | Terminated |
| D-0245-2019 | 10-26-2018 | Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00 | Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing. | RemedyRepack Inc. / 1 vial | Class III | Terminated |
| D-0221-2019 | 10-26-2018 | Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441. | CGMP Deviations: Product was released to market prior to microbiological testing. | S.C. Johnson Professional / 258 cases | Class II | Terminated |
| D-0127-2019 | 10-24-2018 | Irbesartan Bulk Active Pharmaceutical Ingredient. | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. | Aurobindo Pharma Limited (Unit I) / 1724.8 kgs. | Class II | Terminated |
| D-0218-2019 | 10-23-2018 | Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day Regimen per pouch, packaged in a) 6 Veridate Tablet Dispensers and 6 Refill pouches (NDC 504-58-178-28) per carton (NDC 50458-178-06); and b) 12 Veridate Tablet Dispenser Refills (NDC 50458-178-12) per carton (NDC 50458-178-12), Clinic Package, , Rx Only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560. | Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser. | Janssen Pharmaceuticals, Inc. / a) 3,956 cartons; b) 1 carton | Class II | Terminated |
| D-0217-2019 | 10-23-2018 | Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560. | Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser. | Janssen Pharmaceuticals, Inc. / 1,777 cartons | Class II | Terminated |
| D-0128-2019 | 10-22-2018 | Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01 | Failed Dissolution Specifications: OOS resultsduring routine stability testing | Boehringer Ingelheim Pharmaceuticals, Inc. / 1,380 100-count bottles | Class II | Terminated |
| D-0133-2019 | 10-19-2018 | Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 360 bags | Class II | Terminated |
| D-0134-2019 | 10-19-2018 | Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 300 bags | Class II | Terminated |
| D-0131-2019 | 10-19-2018 | Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 1,360 bags | Class II | Terminated |
| D-0129-2019 | 10-19-2018 | Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01 | Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing. | Teva Pharmaceuticals USA / 53,451 bottles | Class II | Terminated |
| D-0135-2019 | 10-19-2018 | Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 300 bags | Class II | Terminated |
| D-0132-2019 | 10-19-2018 | Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 / 20 syringes | Class II | Terminated |
| D-0277-2019 | 10-19-2018 | children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5. Package NDCs: 56062-106-08 | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. | Taro Pharmaceuticals U.S.A., Inc. / 8328 bottles | Class II | Terminated |
| D-0278-2019 | 10-19-2018 | children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4. | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. | Taro Pharmaceuticals U.S.A., Inc. / | Class II | Terminated |
| D-0276-2019 | 10-19-2018 | Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2. | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. | Taro Pharmaceuticals U.S.A., Inc. / 12,432 bottles | Class II | Terminated |
| D-0239-2019 | 10-18-2018 | Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684 | Presence of precipitate | Promise Pharmacy LLC / N/A | Class III | Terminated |
| D-0415-2019 | 10-18-2018 | GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00 | Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing. | H J Harkins Company Inc dba Pharma Pac / 84, 5 ml bottles | Class II | Terminated |
| D-0229-2019 | 10-17-2018 | Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0233-2019 | 10-17-2018 | Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0237-2019 | 10-17-2018 | Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0227-2019 | 10-17-2018 | Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0236-2019 | 10-17-2018 | Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0228-2019 | 10-17-2018 | Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0226-2019 | 10-17-2018 | Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0238-2019 | 10-17-2018 | Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30 count (NDC 69761-222-30) vials, Rx Only, Qualgen, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0235-2019 | 10-17-2018 | Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0234-2019 | 10-17-2018 | Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0231-2019 | 10-17-2018 | Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0232-2019 | 10-17-2018 | Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0225-2019 | 10-17-2018 | Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0230-2019 | 10-17-2018 | Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06), 12 count (NDC 69761-006-12), and 30 count (NDC 69761-006-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013 | Lack of Assurance of Sterility | Qualgen, LLC / | Class II | Terminated |
| D-0094-2019 | 10-15-2018 | Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31 Package NDCs: 23155-216-31; 3231552163 | Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle | Heritage Pharmaceuticals, Inc. / 2,789 Units | Class II | Terminated |
| D-0246-2019 | 10-15-2018 | Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA | Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine | Zero Xtreme USA / 16 bottles | Class II | Terminated |
| D-0222-2019 | 10-15-2018 | Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10 Package NDCs: 36000-033-10 | Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots. | Baxter Healthcare Corporation / 402,165 vials | Class III | Terminated |
| D-0083-2019 | 10-11-2018 | HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80. Package NDCs: 54838-502-80 | CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities. | Lannett Company, Inc. / 8,324 bottles | Class II | Terminated |
| D-0087-2019 | 10-09-2018 | Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11 Package NDCs: 68180-943-11 | Defective Container: Repetitive complaints received indicating pump not working. | Lupin Pharmaceuticals Inc. / 6,752 bottles | Class III | Terminated |
| D-0116-2019 | 10-09-2018 | Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0030-1 and Tester NDC 61096-1030-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 2,956 bottles | Class II | Terminated |
| D-0115-2019 | 10-09-2018 | TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879NDC 61096-0007-1. and Tester NDC 61096-1007-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 1,307 bottles | Class II | Terminated |
| D-0107-2019 | 10-09-2018 | Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0033-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 2,054 bottles | Class II | Terminated |
| D-0114-2019 | 10-09-2018 | SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0001-1 and Tester NDC 6196-1001-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 5,393 bottles | Class II | Terminated |
| D-0118-2019 | 10-09-2018 | Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0024-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 1,055 bottles | Class II | Terminated |
| D-0121-2019 | 10-09-2018 | Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879NDC 61096-0023-1 and Tester NDC 61096-1023-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 1,473 bottles | Class II | Terminated |
| D-0126-2019 | 10-09-2018 | Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0004-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 3634 bottles | Class II | Terminated |
| D-0122-2019 | 10-09-2018 | ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0038-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 2,837 bottles | Class II | Terminated |
| D-0113-2019 | 10-09-2018 | DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0005-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 1,465 bottles | Class II | Terminated |
| D-0124-2019 | 10-09-2018 | Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0027-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 919 bottles | Class II | Terminated |
| D-0105-2019 | 10-09-2018 | Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0035-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 1,558 bottles | Class II | Terminated |
| D-0108-2019 | 10-09-2018 | Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0034-1 and Tester NDC 61096-1034-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 1,284 bottles | Class II | Terminated |
| D-0109-2019 | 10-09-2018 | MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0014-1 and Tester NDC 61096-1014 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 2,301 bottles | Class II | Terminated |
| D-0111-2019 | 10-09-2018 | AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0003-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 4,153 bottles | Class II | Terminated |
| D-0119-2019 | 10-09-2018 | Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0006-1 and Tester NDC 61096-1006-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 3,896 bottles | Class II | Terminated |
| D-0106-2019 | 10-09-2018 | Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0025-1 and Tester NDC 61096-1025-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 830 bottles | Class II | Terminated |
| D-0120-2019 | 10-09-2018 | PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0031-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 647 bottles | Class II | Terminated |
| D-0125-2019 | 10-09-2018 | Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0039-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 2,595 bottles | Class II | Terminated |
| D-0110-2019 | 10-09-2018 | Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0012-1 and Tester NDC 61096-1012-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 731 bottles | Class II | Terminated |
| D-0123-2019 | 10-09-2018 | Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0017-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 857 bottles | Class II | Terminated |
| D-0112-2019 | 10-09-2018 | Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0002-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 2,565 bottles | Class II | Terminated |
| D-0117-2019 | 10-09-2018 | Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0032-1 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Sprayology / 3,531 bottles | Class II | Terminated |
| D-0216-2019 | 10-08-2018 | 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045 | Lack of Assurance of Sterility; bags have the potential to leak | ICU Medical Inc / 2,580,448 bags | Class II | Terminated |
| D-0215-2019 | 10-08-2018 | 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045 | Lack of Assurance of Sterility; bags have the potential to leak | ICU Medical Inc / 372,912 bags | Class II | Terminated |
| D-0414-2019 | 10-08-2018 | Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10 | Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing. | Akorn, Inc. / 149,159 5mL bottles | Class II | Terminated |
| D-0092-2019 | 10-05-2018 | Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60 Package NDCs: 43386-069-60 | Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis | LUPIN SOMERSET / 2712 60-ml bottles | Class II | Terminated |
| D-0219-2019 | 10-05-2018 | Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99 Package NDCs: 51267-890-99; 51267-890-07 | Container packaging defect. | Orexigen Therapeutics, Inc. / 18,895 bottles | Class III | Terminated |
| D-0249-2019 | 10-05-2018 | Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071. | Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing. | Amerigen Pharmaceuticals Inc. / 5,232 bottles: a) 4,146 bottles; b) 1,086 bottles | Class III | Terminated |
| D-0254-2019 | 10-03-2018 | Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-151-59 | Microbial Contamination of Non-Sterile Product | Silver Star Brands / 931 bottles | Class I | Terminated |
| D-0256-2019 | 10-03-2018 | Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Silver Star Brands / 247 bottles | Class II | Terminated |
| D-0255-2019 | 10-03-2018 | Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-204-02 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Silver Star Brands / 247 bottles | Class II | Terminated |
| D-0251-2019 | 10-03-2018 | Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02 | Microbial Contamination of Non-Sterile Products | Silver Star Brands / 67 bottles | Class I | Terminated |
