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-0560-2023 | 04-06-2023 | Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90) | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. / 520 bottles | Class II | Terminated |
| D-0559-2023 | 04-06-2023 | Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90 | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. / 186 bottles | Class II | Terminated |
| D-0561-2023 | 04-06-2023 | Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90) | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. / 393 bottles | Class II | Terminated |
| D-0557-2023 | 04-06-2023 | Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30 | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. / 352 bottles | Class II | Terminated |
| D-0564-2023 | 03-31-2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets | CGMP deviation: product outside labeled storage temperature requirements. | Family Dollar Stores, Llc. / Pending | Class II | Ongoing |
| D-0566-2023 | 03-31-2023 | Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles. | CGMP deviation: product outside labeled storage temperature requirements. | Family Dollar Stores, Llc. / Pending | Class II | Ongoing |
| D-0565-2023 | 03-31-2023 | Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles | CGMP deviation: product outside labeled storage temperature requirements. | Family Dollar Stores, Llc. / | Class II | Ongoing |
| D-0563-2023 | 03-31-2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets. | CGMP deviation: product outside labeled storage temperature requirements. | Family Dollar Stores, Llc. / Pending. | Class II | Ongoing |
| D-0529-2023 | 03-29-2023 | Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC 47335-615-44); Rx only, Manufactured by: Gland Pharma Limited, Hyderabad-502307 India; Distributed by: Sun Phamaceutical Industries, Inc., Cranbury, NJ 08512. Package NDCs: 47335-615-44; 47335-615-40 | Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring. | SUN PHARMACEUTICAL INDUSTRIES INC / 16,450 vials | Class III | Terminated |
| D-0528-2023 | 03-29-2023 | Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08. | Sub-potent drug: assay test result below specifications at 9-month timepoint. | Accord Healthcare, Inc. / 4574 cartons | Class III | Terminated |
| D-0872-2023 | 03-27-2023 | Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01 | CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products. | Jarman's Midwest Cleaning Systems, Inc. / 1276 gallons | Class II | Terminated |
| D-0874-2023 | 03-27-2023 | SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon / 3785.41ml, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. | Chemical Contamination: FDA testing found Presence of methanol | Jarman's Midwest Cleaning Systems, Inc. / 7303 gallons | Class I | Terminated |
| D-0873-2023 | 03-27-2023 | Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. | Chemical Contamination: FDA testing found Presence of methanol | Jarman's Midwest Cleaning Systems, Inc. / 2365 gallons | Class I | Terminated |
| D-0531-2023 | 03-27-2023 | Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging). Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150, Office Use Only, Not for Resale. Secondary packaging consists of a coated cardboard box, with order-specific label indicating lot number housed within order/container. NDC # 69194-0458-1 | Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. | Pine Pharmaceuticals, LLC / 932 syringes | Class III | Terminated |
| D-0510-2023 | 03-27-2023 | Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19 | Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. | Teva Pharmaceuticals USA Inc / 3,772 cartons | Class III | Terminated |
| D-0505-2023 | 03-27-2023 | Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination. | Preferred Pharmaceuticals, Inc. / 320 x 30-count; 46 x 60-count; 10 x 90-count bottles | Class II | Terminated |
| D-0506-2023 | 03-27-2023 | Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination. | Preferred Pharmaceuticals, Inc. / 33 x 30-count; 78 x 60-count bottles | Class II | Terminated |
| D-0504-2023 | 03-27-2023 | Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3 | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination. | Preferred Pharmaceuticals, Inc. / 30 Bottles | Class II | Terminated |
| D-0515-2023 | 03-23-2023 | Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 4 Bottles | Class II | Ongoing |
| D-0521-2023 | 03-23-2023 | Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 24 Bottles | Class II | Ongoing |
| D-0514-2023 | 03-23-2023 | Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 3 Bottles | Class II | Ongoing |
| D-0512-2023 | 03-23-2023 | Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / a) 375 Bottles b) 323 Bottles | Class II | Ongoing |
| D-0513-2023 | 03-23-2023 | Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 72 Bottles | Class II | Ongoing |
| D-0511-2023 | 03-23-2023 | Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 158 Bottles | Class II | Ongoing |
| D-0516-2023 | 03-23-2023 | Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / a) 135 Bottles, b) 24 Bottles | Class II | Ongoing |
| D-0519-2023 | 03-23-2023 | Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703. Package NDCs: 68788-7086-2; 68788-7086-3; 68788-7086-6; 68788-7086-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / a) 59 Bottles, b) 77 Bottles | Class II | Ongoing |
| D-0520-2023 | 03-23-2023 | Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 264 Bottles | Class II | Ongoing |
| D-0517-2023 | 03-23-2023 | Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 17 Bottles | Class II | Ongoing |
| D-0527-2023 | 03-23-2023 | Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 15 Bottles | Class II | Ongoing |
| D-0523-2023 | 03-23-2023 | Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 57 Bottles | Class II | Ongoing |
| D-0518-2023 | 03-23-2023 | Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / a) 266 Bottles, b) not reported, c) 216 Bottles | Class II | Ongoing |
| D-0524-2023 | 03-23-2023 | Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / a) 305 Bottles, b) 72 Bottles, c) 617 Bottles | Class II | Ongoing |
| D-0525-2023 | 03-23-2023 | Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / a) 88 Bottles, b) 3 Bottles, c) 175 Bottles | Class II | Ongoing |
| D-0522-2023 | 03-23-2023 | Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 82 Bottles of 90 Tablets | Class II | Ongoing |
| D-0526-2023 | 03-23-2023 | Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7 Package NDCs: 68788-8153-7 | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. / 32 Bottles | Class II | Ongoing |
| D-0508-2023 | 03-22-2023 | Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534. | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. | Direct Rx / 349 bottles | Class II | Ongoing |
| D-0509-2023 | 03-22-2023 | Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60. | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. | Direct Rx / 9 bottles | Class II | Ongoing |
| D-0507-2023 | 03-22-2023 | Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30. | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. | Direct Rx / 20 bottles | Class II | Ongoing |
| D-0500-2023 | 03-20-2023 | Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00 | cGMP Deviations | RemedyRepack Inc. / 132 bottles | Class II | Terminated |
| D-0502-2023 | 03-20-2023 | Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. | cGMP Deviations | RemedyRepack Inc. / a) 76 bottles, b)151 bottles | Class II | Terminated |
| D-0490-2023 | 03-20-2023 | Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03 | cGMP Deviations | RemedyRepack Inc. / 3 bottles | Class II | Terminated |
| D-0496-2023 | 03-20-2023 | Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 | cGMP Deviations | RemedyRepack Inc. / a) 1,262 bottles, b) 95 bottles | Class II | Terminated |
| D-0501-2023 | 03-20-2023 | Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. | cGMP Deviations | RemedyRepack Inc. / a) 399 bottles, b)445 bottles | Class II | Terminated |
| D-0498-2023 | 03-20-2023 | Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. | cGMP Deviations | RemedyRepack Inc. / 3,426 bottles | Class II | Terminated |
| D-0493-2023 | 03-20-2023 | Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 | cGMP Deviations | RemedyRepack Inc. / a) 147 bottles, b)70 bottles, c) 3 bottles | Class II | Terminated |
| D-0495-2023 | 03-20-2023 | Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00. | cGMP Deviations | RemedyRepack Inc. / 399 bottles | Class II | Terminated |
| D-0499-2023 | 03-20-2023 | Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00 | cGMP Deviations | RemedyRepack Inc. / 3 bottles | Class II | Terminated |
| D-0494-2023 | 03-20-2023 | Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00. | cGMP Deviations | RemedyRepack Inc. / 17 bottles | Class II | Terminated |
| D-0503-2023 | 03-20-2023 | Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 | cGMP Deviations | RemedyRepack Inc. / | Class II | Terminated |
| D-0491-2023 | 03-20-2023 | Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. | cGMP Deviations | RemedyRepack Inc. / a) 3,497 bottles, b) 729 bottles | Class II | Terminated |
| D-0497-2023 | 03-20-2023 | Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00 | cGMP Deviations | RemedyRepack Inc. / 16 bottles | Class II | Terminated |
| D-0492-2023 | 03-20-2023 | Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. | cGMP Deviations | RemedyRepack Inc. / a) 58 bottles, b) 6 bottles | Class II | Terminated |
| D-0758-2023 | 03-17-2023 | Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC / 105,361 bottles | Class II | Terminated |
| D-0757-2023 | 03-17-2023 | Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC / 63,335 bottles | Class II | Terminated |
| D-0759-2023 | 03-17-2023 | Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories | CGMP Deviations: recalling drug products following an FDA inspection. | Amerisource Health Services LLC / 129,849 bottles | Class II | Terminated |
| D-0539-2023 | 03-17-2023 | Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05 Package NDCs: 67877-431-03; 67877-431-01; 67877-431-05; 67877-431-33; 67877-431-38; 67877-431-32; 67877-432-03; 67877-432-01; 67877-432-05; 67877-432-33; 67877-432-38; 67877-432-32; 67877-433-03; 67877-433-01; 67877-433-05; 67877-433-33; 67877-433-38; 67877-433-32; 67877-434-03; 67877-434-01; 67877-434-05; 67877-434-33; 67877-434-38; 67877-435-03; 67877-435-01; 67877-435-05; 67877-435-33; 67877-435-38; 67877-430-03; 67877-430-01; 67877-430-05; 67877-430-33; 67877-430-38; 67877-430-32 | Out of specification (OOS) for Spectroscopic Identification test by IR. | Ascend Laboratories, LLC / 135 bottles | Class II | Ongoing |
| D-0548-2023 | 03-16-2023 | Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52 Package NDCs: 51655-946-52 | CGMP Deviations | Northwind Pharmaceuticals LLC / 99 bottles | Class II | Ongoing |
| D-0554-2023 | 03-16-2023 | Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52 Package NDCs: 51655-487-52 | CGMP Deviations | Northwind Pharmaceuticals LLC / 23 bottles | Class II | Ongoing |
| D-0536-2023 | 03-16-2023 | Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-504-01; NDC Unit Dose: 60687-504-11, barcode (01) 003 60687 504 11 7. | Failed Dissolution Specifications: Out of specification dissolution results above specified values. | Amerisource Health Services LLC / 695 cartons | Class II | Terminated |
| D-0535-2023 | 03-16-2023 | Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-13 Package NDCs: 24357-011-13; 42023-159-25; 68599-5804-1 | Labeling; Incorrect NDC number on outer carton of product. | Focus Health Group Inc / 246 kits | Class III | Ongoing |
| D-0550-2023 | 03-16-2023 | Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-109-52 Package NDCs: 51655-109-52 | CGMP Deviations | Northwind Pharmaceuticals LLC / 33 bottles | Class II | Ongoing |
| D-0553-2023 | 03-16-2023 | Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. Package NDCs: 51655-473-54; 51655-473-87 | CGMP Deviations | Northwind Pharmaceuticals LLC / a)164 bottles; b) 198 bottles | Class II | Ongoing |
| D-0549-2023 | 03-16-2023 | BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52 Package NDCs: 51655-511-52 | CGMP Deviations | Northwind Pharmaceuticals LLC / 6 bottles | Class II | Ongoing |
| D-0552-2023 | 03-16-2023 | Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. Package NDCs: 51655-120-52; 51655-120-26 | CGMP Deviations | Northwind Pharmaceuticals LLC / a) 198 bottles; b) 22 bottles | Class II | Ongoing |
| D-0551-2023 | 03-16-2023 | Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. Package NDCs: 51655-383-26; 51655-383-52 | CGMP Deviations | Northwind Pharmaceuticals LLC / a) 230 bottles; b) 22 bottles | Class II | Ongoing |
| D-0542-2023 | 03-15-2023 | Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Package NDCs: 0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0427-52; 0941-0427-53; 0941-0429-52; 0941-0429-53; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0484-01; 0941-0487-01; 0941-0490-01 | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. | Baxter Healthcare Corporation / a) 95,448 bags; b) 174,522 bags | Class II | Completed |
| D-0543-2023 | 03-15-2023 | Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04. Package NDCs: 0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0427-52; 0941-0427-53; 0941-0429-52; 0941-0429-53; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0484-01; 0941-0487-01; 0941-0490-01 | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. | Baxter Healthcare Corporation / 9,788 bags | Class II | Completed |
| D-0530-2023 | 03-14-2023 | Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10 Package NDCs: 31722-712-90; 31722-712-32; 31722-712-31; 31722-713-90; 31722-713-32; 31722-713-31; 31722-713-10 | CGMP Deviations: Discoloration | Hetero USA Inc / 2,352 bottles | Class II | Ongoing |
| D-0533-2023 | 03-14-2023 | Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60. Package NDCs: 67877-475-60; 67877-474-60; 67877-624-60; 67877-624-31 | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. | Ascend Laboratories, LLC / 13,560 bottles | Class II | Ongoing |
| D-0534-2023 | 03-14-2023 | Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60. Package NDCs: 67877-475-60; 67877-474-60; 67877-624-60; 67877-624-31 | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. | Ascend Laboratories, LLC / 12,804 bottles | Class II | Ongoing |
| D-0479-2023 | 03-13-2023 | Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 | cGMP deviations | Direct Rx / 4 bottles | Class II | Terminated |
| D-0480-2023 | 03-13-2023 | Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 | cGMP deviations | Direct Rx / 30 count: 4 bottles; 90 count: 172 bottles | Class II | Terminated |
| D-0478-2023 | 03-13-2023 | Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 | cGMP deviations | Direct Rx / 9 bottles | Class II | Terminated |
| D-0567-2023 | 03-13-2023 | Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC# 31722-629-21. Package NDCs: 31722-629-21 | Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product. | Camber Pharmaceuticals Inc. / 1568 bottles | Class I | Ongoing |
| D-0486-2023 | 03-13-2023 | Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 | cGMP deviations | Direct Rx / 269 bottles | Class II | Terminated |
| D-0481-2023 | 03-13-2023 | Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 | cGMP deviations | Direct Rx / 30 count: 12 bottles; 90 count: 253 bottles | Class II | Terminated |
| D-0483-2023 | 03-13-2023 | Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 | cGMP deviations | Direct Rx / 51 bottles | Class II | Terminated |
| D-0484-2023 | 03-13-2023 | Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 | cGMP deviations | Direct Rx / 30 count: 6 bottles; 90 count: 106 bottles | Class II | Terminated |
| D-0482-2023 | 03-13-2023 | Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 | cGMP deviations | Direct Rx / 30 count: 7 bottles; 90 count: 395 bottles | Class II | Terminated |
| D-0485-2023 | 03-13-2023 | Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 | cGMP deviations | Direct Rx / 30 count: 5 bottles; 90 count: 53 bottles | Class II | Terminated |
| D-0477-2023 | 03-13-2023 | Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx | cGMP deviations | Direct Rx / 19 bottles | Class II | Terminated |
| D-0476-2023 | 03-13-2023 | Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 | cGMP deviations | Direct Rx / 90 count: 495 bottles; 30 count: 13 bottles | Class II | Terminated |
| D-0471-2023 | 03-10-2023 | Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for shear. | Noven Pharmaceuticals Inc / N/A | Class II | Ongoing |
| D-0473-2023 | 03-10-2023 | Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3 Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for shear. | Noven Pharmaceuticals Inc / N/A | Class II | Ongoing |
| D-0472-2023 | 03-10-2023 | Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for shear. | Noven Pharmaceuticals Inc / N/A | Class II | Ongoing |
| D-0470-2023 | 03-10-2023 | Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of specification for shear. | Noven Pharmaceuticals Inc / N/A | Class II | Ongoing |
| D-0468-2023 | 03-09-2023 | JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company Indianapolis, IN 46285 USA Package NDCs: 0597-0152-90; 0597-0152-07; 0597-0152-70; 0597-0152-37; 0597-0152-30; 0597-0153-37; 0597-0153-30; 0597-0153-90; 0597-0153-07; 0597-0153-70 | Labeling: Label Mix-up | Boehringer Ingelheim Pharmaceuticals, Inc. / 69,375 bottles | Class II | Terminated |
| D-0474-2023 | 03-09-2023 | Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86 | Failed Content Uniformity Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / 1,920 bottles | Class III | Terminated |
| D-0532-2023 | 03-08-2023 | MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02 Package NDCs: 70255-010-02; 70255-010-03 | Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025. | Pfizer Inc. / 1,926 Bottles | Class III | Ongoing |
| D-0462-2023 | 03-02-2023 | Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01 | CGMP Deviations: Potential risk of Cross Contamination | Breckenridge Pharmaceutical, Inc / N/A | Class II | Terminated |
| D-0463-2023 | 03-02-2023 | Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-901-01 | CGMP Deviations: Potential risk of Cross Contamination | Breckenridge Pharmaceutical, Inc / N/A | Class II | Terminated |
| D-0475-2023 | 03-02-2023 | Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11. Package NDCs: 49884-161-11 | Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay. | Endo Pharmaceuticals, Inc. / 372,938 bottles | Class II | Terminated |
| D-0461-2023 | 03-02-2023 | Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037. | CGMP Deviations: Potential risk of Cross Contamination | Breckenridge Pharmaceutical, Inc / N/A | Class II | Terminated |
| D-0459-2023 | 03-02-2023 | Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037. | CGMP Deviations: Potential risk of Cross Contamination | Breckenridge Pharmaceutical, Inc / N/A | Class II | Terminated |
| D-0458-2023 | 03-02-2023 | Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037. | CGMP Deviations: Potential risk of Cross Contamination | Breckenridge Pharmaceutical, Inc / N/A | Class II | Terminated |
| D-0460-2023 | 03-02-2023 | Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037. | CGMP Deviations: Potential risk of Cross Contamination | Breckenridge Pharmaceutical, Inc / N/A | Class II | Terminated |
| D-0434-2023 | 03-01-2023 | Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20. Package NDCs: 0264-9567-10; 0264-9577-10; 0264-9587-20 | Subpotent Drug: low Anti-Factor IIa potency. | B. Braun Medical Inc / 30672 | Class II | Terminated |
| D-0433-2023 | 03-01-2023 | Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 15 mL dropper bottle, NDC 60505-0564-3, UPC 3 60505 05643 9; Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326 Package NDCs: 60505-0564-1; 60505-0564-2; 60505-0564-3 | Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility. | Apotex Corp. / 67,056 bottles | Class II | Completed |
| D-0435-2023 | 02-28-2023 | Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01 Package NDCs: 25021-404-01 | Labeling: Not elsewhere classified | Sagent Pharmaceuticals Inc / 28,875 vials | Class II | Terminated |
| D-0450-2023 | 02-24-2023 | Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756 | CGMP DEVIATIONS | Ecometics, Inc. / 37,968 metal tube/folding carton | Class II | Terminated |
