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 September 05, 2025 and include a total of 17050 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1548-2019 | 04-01-2019 | TOOTSIE ROLL FRUIT CHEWS LEMON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 8,856 | Class III | Terminated |
| D-1536-2019 | 04-01-2019 | Tootsie Roll POP CHOCOLATE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 5112 | Class III | Terminated |
| D-1540-2019 | 04-01-2019 | DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 3852 | Class III | Terminated |
| D-1537-2019 | 04-01-2019 | Tootsie Roll POP RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 5112 | Class III | Terminated |
| D-1534-2019 | 04-01-2019 | Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 50,000 | Class III | Terminated |
| D-1546-2019 | 04-01-2019 | AMERICA'S ORIGINAL DUBBLE BUBBLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 20160 | Class III | Terminated |
| D-1554-2019 | 04-01-2019 | AIR HEADS PINK LEMONADE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1552-2019 | 04-01-2019 | AIR HEADS STRAWBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1530-2019 | 04-01-2019 | Good to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in China for Cashco Distributors Inc. 6430 N. E. Columbia Blvd Portland OR 97218 | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 52,160 | Class III | Terminated |
| D-1531-2019 | 04-01-2019 | Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL Enterprises, Inc. Cleveland, Ohio 44102, Made in China | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 5112 | Class III | Terminated |
| D-1533-2019 | 04-01-2019 | festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen Distributed by: festpak - Austin, TX 78732 Made in China | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 20, 000 | Class III | Terminated |
| D-1562-2019 | 04-01-2019 | DIPPIN' DOTS SCENTED COOKIES 'N CREAM ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1121-2019 | 04-01-2019 | Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06 Package NDCs: 68180-196-06; 68180-196-09; 68180-196-12; 68180-197-06; 68180-197-09; 68180-197-12; 68180-197-07; 68180-198-06; 68180-198-09; 68180-198-12; 68180-199-06; 68180-199-09; 68180-199-12 | Failed Impurities/Degradation Specifications; 18 month long term stability study. | Lupin Pharmaceuticals Inc. / 12,504 bottles | Class III | Terminated |
| D-1074-2019 | 03-29-2019 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90. | Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets. | Jubilant Cadista Pharmaceuticals, Inc. / 12,960 bottles | Class II | Terminated |
| D-1084-2019 | 03-29-2019 | Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1. Package NDCs: 39822-2000-1; 39822-2010-1 | Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL. | X-Gen Pharmaceuticals Inc. / 24,966 vials | Class III | Terminated |
| D-1080-2019 | 03-28-2019 | Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16 | Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing. | Akorn, Inc. / 2,796 bottles | Class III | Terminated |
| D-1248-2019 | 03-28-2019 | Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05 Package NDCs: 76420-782-01; 0517-0720-01; 55150-162-05; 0409-1159-18; 67777-419-02 | Presence of Particulate Matter: One vial was found to contain a hair. | Aurobindo Pharma USA Inc. / 88600 vials | Class I | Terminated |
| D-1134-2019 | 03-26-2019 | Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi) Volume: 8.8 mL vial, Rx Only, Mfg. by GE Healthcare, Medi-physics, Inc., Arlington Heights, IL 60004. NDC: 17156-299-18 | Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product. | Medi-Physics Inc. dba GE Healthcare / 110 10 ml vials | Class III | Terminated |
| D-1120-2019 | 03-25-2019 | Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05 Package NDCs: 68462-195-90; 68462-195-05; 68462-196-90; 68462-196-05; 68462-197-90; 68462-197-05; 68462-198-90; 68462-198-05 | Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg. | Glenmark Pharmaceuticals Inc., USA / 2076 500-count Bottles | Class II | Terminated |
| D-1131-2019 | 03-25-2019 | Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02 | Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. | Lohxa LLC / 46 boxes - 1380 unit dose cups | Class II | Terminated |
| D-1130-2019 | 03-25-2019 | Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01 | Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. | Lohxa LLC / 5 boxes - 250 unit dose cups. | Class II | Terminated |
| D-1082-2019 | 03-22-2019 | Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630. | Failed pH Specification: product does not meet pH label claim. | Auro Pharmacies Inc. DBA Central Drugs / 167 vials | Class III | Terminated |
| D-1057-2019 | 03-22-2019 | Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA. | Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study. | Lupin Pharmaceuticals Inc. / 12,464 cartons | Class II | Terminated |
| D-1124-2019 | 03-22-2019 | Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-31. Package NDCs: 69097-536-37; 69097-537-37; 69097-537-31 | Presence of Particulate Matter. | InvaGen Pharmaceuticals, Inc. / 692538 vials | Class II | Terminated |
| D-1123-2019 | 03-22-2019 | Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-37. Package NDCs: 69097-536-37; 69097-537-37; 69097-537-31 | Presence of Particulate Matter. | InvaGen Pharmaceuticals, Inc. / 12234 vials | Class II | Terminated |
| D-1125-2019 | 03-22-2019 | Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-536-37. Package NDCs: 69097-536-37; 69097-537-37; 69097-537-31 | Presence of Particulate Matter. | InvaGen Pharmaceuticals, Inc. / 75968 vials | Class II | Terminated |
| D-1056-2019 | 03-19-2019 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05 Package NDCs: 0023-9211-03; 0023-9211-05; 0023-9211-10; 0023-9211-15 | cGMP Deviations | Allergan Sales, LLC / 72 bottles | Class II | Terminated |
| D-1113-2019 | 03-19-2019 | Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD NDC 43386-050-19 UPC 343386050192 a) Lemon Flavor Pack net wt. 2 g UPC 343386200023 b) Orange Flavor Pack net wt. 2 g UPC 343386202027 c) Cherry Flavor Pack net wt. 2 g UPC 3433862034 Package NDCs: 43386-050-19; 3433860501; 3433862000; 3433862020; 3433862034 | Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient | LUPIN SOMERSET / 76422 bottles | Class II | Terminated |
| D-1058-2019 | 03-18-2019 | Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05. | Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking. | Ingenus Pharmaceuticals Llc / 29,435 bottles | Class III | Terminated |
| D-1073-2019 | 03-15-2019 | 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02 | Presence of Particulate Matter; glass particulates | Pfizer Inc. / 283,400 vials | Class I | Terminated |
| D-1070-2019 | 03-15-2019 | Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94 | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point | Pfizer Inc. / 701 cartons (25 vials per carton) | Class III | Terminated |
| D-1071-2019 | 03-15-2019 | Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94 | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point | Pfizer Inc. / 8,878 cartons (25 vials per carton) | Class III | Terminated |
| D-1072-2019 | 03-15-2019 | Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94 | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point | Pfizer Inc. / 8,320 cartons (25 vials per carton) | Class III | Terminated |
| D-1132-2019 | 03-15-2019 | Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a 50 mL silver jar with a silver cap, Clinique Laboratories, Dist. New York, NY 10022 | Defective container: Ineffective seal between the cap and jar of the affected product. | Estee Lauder Inc / 14490 jars | Class III | Terminated |
| D-1067-2019 | 03-15-2019 | Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02 Package NDCs: 0009-0870-21; 0009-0870-26; 0009-0775-20; 0009-0775-26; 0009-0902-11; 0009-0902-18; 0009-0728-05; 0009-0728-09; 0009-3124-01; 0009-3124-03; 0009-3447-01; 0009-3447-03; 0009-3381-01; 0009-3381-02; 0009-3375-01; 0009-3375-02; 0009-3382-01; 0009-3382-02; 0009-6582-02; 0009-6582-01 | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point | Pfizer Inc. / 67 cartons (25 vials per carton) | Class III | Terminated |
| D-1068-2019 | 03-15-2019 | Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01 Package NDCs: 0009-0870-21; 0009-0870-26; 0009-0775-20; 0009-0775-26; 0009-0902-11; 0009-0902-18; 0009-0728-05; 0009-0728-09; 0009-3124-01; 0009-3124-03; 0009-3447-01; 0009-3447-03; 0009-3381-01; 0009-3381-02; 0009-3375-01; 0009-3375-02; 0009-3382-01; 0009-3382-02; 0009-6582-02; 0009-6582-01 | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point | Pfizer Inc. / 820 cartons (25 vials per carton) | Class III | Terminated |
| D-1069-2019 | 03-15-2019 | Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017. NDC 0009-3447-01 Package NDCs: 0009-0870-21; 0009-0870-26; 0009-0775-20; 0009-0775-26; 0009-0902-11; 0009-0902-18; 0009-0728-05; 0009-0728-09; 0009-3124-01; 0009-3124-03; 0009-3447-01; 0009-3447-03; 0009-3381-01; 0009-3381-02; 0009-3375-01; 0009-3375-02; 0009-3382-01; 0009-3382-02; 0009-6582-02; 0009-6582-01 | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point | Pfizer Inc. / 500 cartons (25 vials per carton) | Class III | Terminated |
| D-1085-2019 | 03-14-2019 | Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0 | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein. | Ata International Inc / Unknown | Class I | Terminated |
| D-1081-2019 | 03-14-2019 | Losartan 50mg Tablet, 30 count each blister card. | CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA). | RemedyRepack Inc. / 33 blister cards of 30 = 990 tablets | Class II | Terminated |
| D-1034-2019 | 03-13-2019 | Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use syringe, NDC: 42852-882-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 975 | Class II | Terminated |
| D-1020-2019 | 03-13-2019 | Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC: 42852-830-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 16075 syringes | Class II | Terminated |
| D-1026-2019 | 03-13-2019 | 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 1540 syringes | Class II | Terminated |
| D-1024-2019 | 03-13-2019 | Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 5700 syringes | Class II | Terminated |
| D-1025-2019 | 03-13-2019 | Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 140 syringes | Class II | Terminated |
| D-1018-2019 | 03-13-2019 | fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 180 bags | Class II | Terminated |
| D-1033-2019 | 03-13-2019 | Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe, NDC: 42852-241-63 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 2325 syringes | Class II | Terminated |
| D-1023-2019 | 03-13-2019 | Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 22900 syringes | Class II | Terminated |
| D-1032-2019 | 03-13-2019 | Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 1850 syringes | Class II | Terminated |
| D-1019-2019 | 03-13-2019 | Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 1125 bags | Class II | Terminated |
| D-1027-2019 | 03-13-2019 | 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 1980 syringes | Class II | Terminated |
| D-1031-2019 | 03-13-2019 | Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe, NDC: 42852-739-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 1440 syringes | Class II | Terminated |
| D-1016-2019 | 03-13-2019 | HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 2400 syringes | Class II | Terminated |
| D-1028-2019 | 03-13-2019 | Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 800 syringes | Class II | Terminated |
| D-1021-2019 | 03-13-2019 | Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 2580 syringes | Class II | Terminated |
| D-1030-2019 | 03-13-2019 | Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 500 syringes | Class II | Terminated |
| D-1017-2019 | 03-13-2019 | fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 360 bags | Class II | Terminated |
| D-1022-2019 | 03-13-2019 | Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 1575 syringes | Class II | Terminated |
| D-1029-2019 | 03-13-2019 | Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 550 syringes | Class II | Terminated |
| D-1010-2019 | 03-13-2019 | 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. / 3,200 bottles | Class III | Terminated |
| D-1127-2019 | 03-12-2019 | Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51 fl oz., Manufactured by: MSM Nutraceuticals, LLC, UPC 8 54582 00119 7. | Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. | MSM Nutraceuticals, LLC / 200 15ml bottles | Class II | Terminated |
| D-1126-2019 | 03-12-2019 | 15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027, UPC 8 54582 00120 3. | Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. | MSM Nutraceuticals, LLC / 5000 30 ml bottles | Class II | Terminated |
| D-1129-2019 | 03-12-2019 | Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology Drive, Deerfield BEach, FL 33441 SKU#182 UPC 00854582001036 | Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. | MSM Nutraceuticals, LLC / 500 30 mL bottles | Class II | Terminated |
| D-1011-2019 | 03-12-2019 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10 | Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature. | Akorn Inc / 15,322 10 ml bottles | Class II | Terminated |
| D-1128-2019 | 03-12-2019 | Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufactured by: MSM Nutraceuticals, LLC , UPC 8 54582 00118 0 | Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71. | MSM Nutraceuticals, LLC / 200 15 ml Bottles | Class II | Terminated |
| D-0032-2021 | 03-12-2019 | Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90 | CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API. | Direct Rx / 33 bottles | Class II | Terminated |
| D-1008-2019 | 03-11-2019 | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8. Package NDCs: 50914-7720-8 | Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured. | Iso-Tex Diagnostics, Inc / 54 syringes | Class II | Terminated |
| D-1006-2019 | 03-11-2019 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0093-3008-93 Package NDCs: 0093-3008-19; 0093-3008-93; 0093-3009-19; 0093-3009-93 | Subpotent Drug. | Teva Pharmaceuticals USA / 7,081 bottles | Class III | Terminated |
| D-0341-2021 | 03-08-2019 | Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90 Package NDCs: 43063-854-60; 43063-854-90; 43063-0854-90 | CGMP deviation: Product found to contain trace amounts of NMBA | PD-Rx Pharmaceuticals, Inc. / 576 bottles | Class II | Terminated |
| D-1012-2019 | 03-07-2019 | Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little Remedies Infant Fever Reducer (acetaminophen 150mg) 2 fl. oz. bottle, Little Remedies Saline Spray/Drops (sodium chloride) 0.5 fl oz., Little Remedies Gripe Water (zingiber officinale (Ginger) Root Extract 5mg, Foeniculum vulgare (Fennel) Seed Extract 4 mg) 2 fl. oz bottle., Little Remedies Gas Relief Drops (simethicone emulsion USP 66.7 mg and simethicone 20 mg) 1 fl. oz., Boudreaux's Butt Paste (zinc oxide 16%) 2 oz. ointment,. Distributed by Medtech Products Inc. Tarrytown, NY, a Prestige Consumer Healthcare Company. UPC 7 56184 00007 6. | Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit. | Medtech Products, Inc. / 4,716 kits | Class II | Terminated |
| D-0991-2019 | 03-07-2019 | Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61. | Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing. | Boehringer Ingelheim Pharmaceuticals, Inc. / 112 folding cartons | Class III | Terminated |
| D-1053-2019 | 03-07-2019 | Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-123-90 | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products | Rising Pharmaceuticals, Inc. / 37,410 bottles | Class II | Ongoing |
| D-1055-2019 | 03-07-2019 | Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-125-90 | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products | Rising Pharmaceuticals, Inc. / 42,016 bottles | Class II | Ongoing |
| D-1054-2019 | 03-07-2019 | Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 ---- NDC 52343-124-90 | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products | Rising Pharmaceuticals, Inc. / 35,281 bottles | Class II | Ongoing |
| D-1052-2019 | 03-07-2019 | Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30 | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products | Rising Pharmaceuticals, Inc. / 30,530 bottles | Class II | Ongoing |
| D-1051-2019 | 03-06-2019 | Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807. | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified. | Preferred Pharmaceuticals, Inc / 530 | Class II | Terminated |
| D-1047-2019 | 03-06-2019 | Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01) | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. | American Health Packaging / 3337 cartons | Class II | Terminated |
| D-1001-2019 | 03-06-2019 | Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40. Package NDCs: 43598-258-11; 43598-259-40; 43598-389-57 | Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance. | Dr. Reddy's Laboratories, Inc. / 5,755 vials | Class II | Terminated |
| D-1044-2019 | 03-05-2019 | Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | AVKARE Inc. / N/A | Class II | Terminated |
| D-1135-2019 | 03-05-2019 | LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz is labeled as LEOPARD Miracle of Honey, UPC 8 699415 912859, Manufactured in Turkey, www leopardhoneytr.com. | Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. | USA LESS Inc. / 83 boxes | Class I | Terminated |
| D-1045-2019 | 03-05-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | AVKARE Inc. / N/A | Class II | Terminated |
| D-1046-2019 | 03-05-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | AVKARE Inc. / N/A | Class II | Terminated |
| D-0994-2019 | 03-04-2019 | ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons per case, Petra Hygienic Systems, Concord, ON L4K 4RS/ Reno, NV 89511, NDC 42326-550-01, UPC 0 65936 10335 5. | Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products. | Petra Hygienic Systems Int Ltd / 58 cases | Class III | Terminated |
| D-1083-2019 | 03-04-2019 | Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side. | CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API). | H J Harkins Company Inc dba Pharma Pac / 300 tablets | Class II | Terminated |
| D-1050-2019 | 03-01-2019 | Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-579-54 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Legacy Pharmaceutical Packaging LLC / 2,497,856 bottles | Class II | Ongoing |
| D-0992-2019 | 03-01-2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb. | Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. | Apotex Inc. / 82,705 cartons | Class II | Completed |
| D-1075-2019 | 03-01-2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected. | Legacy Pharmaceutical Packaging LLC / 179,544 30-count bottles | Class II | Terminated |
| D-1049-2019 | 03-01-2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-578-54 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Legacy Pharmaceutical Packaging LLC / 2,851,284 bottles | Class II | Ongoing |
| D-1048-2019 | 03-01-2019 | Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54 | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Legacy Pharmaceutical Packaging LLC / 456,732 bottles | Class II | Ongoing |
| D-1820-2019 | 03-01-2019 | Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33 | Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples. | American Health Packaging / 13,229 cartons | Class II | Terminated |
| D-0990-2019 | 03-01-2019 | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Package NDCs: 42291-633-01; 42291-633-50; 42291-634-01; 42291-634-50; 42291-635-01 | Failed Dissolution Specifications | AVKARE Inc. / a) 2947 and b) 3379 | Class III | Terminated |
| D-1115-2019 | 02-28-2019 | LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c) 1000-count (NDC: 13668-409-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 476,340 bottles | Class II | Ongoing |
| D-1116-2019 | 02-28-2019 | LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 121,668 bottles | Class II | Ongoing |
| D-1114-2019 | 02-28-2019 | LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 133,992 bottles | Class II | Ongoing |
| D-0519-2019 | 02-28-2019 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD | Failed Dissolution Specifications; 9-monthstability timepoint | Jubilant Cadista Pharmaceuticals, Inc. / a) 3,072 bottles; b) 2,688 bottles | Class III | Terminated |
| D-1119-2019 | 02-28-2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 173,760 bottles | Class II | Ongoing |
| D-1117-2019 | 02-28-2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / N/A | Class II | Ongoing |
| D-1043-2019 | 02-28-2019 | Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-702-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India Package NDCs: 31722-700-30; 31722-700-60; 31722-700-90; 31722-700-05; 31722-700-10; 31722-701-30; 31722-701-60; 31722-701-90; 31722-701-05; 31722-701-10; 31722-702-30; 31722-702-60; 31722-702-90; 31722-702-05; 31722-702-10 | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient | Camber Pharmaceuticals Inc / 683,641 bottles | Class II | Ongoing |
| D-1118-2019 | 02-28-2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b) 90-count (NDC: 13668-117-90) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 172,296 bottles | Class II | Ongoing |
| D-1042-2019 | 02-28-2019 | Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-701-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India Package NDCs: 31722-700-30; 31722-700-60; 31722-700-90; 31722-700-05; 31722-700-10; 31722-701-30; 31722-701-60; 31722-701-90; 31722-701-05; 31722-701-10; 31722-702-30; 31722-702-60; 31722-702-90; 31722-702-05; 31722-702-10 | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient | Camber Pharmaceuticals Inc / 69712 bottles | Class II | Ongoing |
| D-1041-2019 | 02-28-2019 | Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India Package NDCs: 31722-700-30; 31722-700-60; 31722-700-90; 31722-700-05; 31722-700-10; 31722-701-30; 31722-701-60; 31722-701-90; 31722-701-05; 31722-701-10; 31722-702-30; 31722-702-60; 31722-702-90; 31722-702-05; 31722-702-10 | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient | Camber Pharmaceuticals Inc / 351,732 bottles | Class II | Ongoing |
