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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 | 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 |
| D-0448-2023 | 02-24-2023 | Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756 | CGMP DEVIATIONS | Ecometics, Inc. / 20,746 metal tubes/folding cartons | Class II | Terminated |
| D-0452-2023 | 02-24-2023 | Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756 | CGMP DEVIATIONS | Ecometics, Inc. / | Class II | Terminated |
| D-0451-2023 | 02-24-2023 | Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155 | CGMP DEVIATIONS | Ecometics, Inc. / 34,320 bottles | Class II | Terminated |
| D-0449-2023 | 02-24-2023 | Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars | CGMP DEVIATIONS | Ecometics, Inc. / a) 23,993 plastic jar/folding carton and b) 34,284 plastic jar/folding carton | Class II | Terminated |
| D-0446-2023 | 02-24-2023 | Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by: The Larkspur Group Inc. South Norwalk, CT 06854 | CGMP DEVIATIONS | Ecometics, Inc. / 18,000 bottles | Class II | Terminated |
| D-0447-2023 | 02-24-2023 | Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854 | CGMP DEVIATIONS | Ecometics, Inc. / 4,210 metal tubes/folding carton | Class II | Terminated |
| D-0467-2023 | 02-24-2023 | Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manufactured for: NorthStar Rx LLC., Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, c) 100 tablets per bottle, NDC 70710-1351-01, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. | Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine. | Zydus Pharmaceuticals (USA) Inc / 21,936/30 count bottles and 33,096/100 count bottles | Class III | Terminated |
| D-0363-2023 | 02-24-2023 | Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16. | Subpotent Drug | SCA Pharmaceuticals / 2125 syringes | Class III | Terminated |
| D-0488-2023 | 02-24-2023 | Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3. | Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria. | Global Pharma Healthcare Private Limited / 50,000 tubes | Class I | Ongoing |
| D-0469-2023 | 02-23-2023 | Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 678112000708; NDC 67172-504-01. | Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity. | Teva Pharmaceuticals USA Inc / 715,632 bottles | Class II | Terminated |
| D-0364-2023 | 02-23-2023 | Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01 Package NDCs: 0487-6105-01 | CGMP Deviations: Potential product carryover. | Nephron Sc Inc / 325,080 vials | Class II | Terminated |
| D-0432-2023 | 02-23-2023 | Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4 | Packaging defect: observed packaging defect, blister packaging inadequately sealed. | The Harvard Drug Group / 17,586 cartons | Class II | Terminated |
| D-0438-2023 | 02-23-2023 | NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2 | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation / 4004 | Class II | Ongoing |
| D-0440-2023 | 02-23-2023 | NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0 | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation / 1590 | Class II | Ongoing |
| D-0439-2023 | 02-23-2023 | NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp. NaturalCare Park City, UT, 84098 USA | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation / 8,146 | Class II | Ongoing |
| D-0437-2023 | 02-23-2023 | NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9 | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation / 13,974 | Class II | Ongoing |
| D-0441-2023 | 02-22-2023 | Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60 | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. | Teva Pharmaceuticals USA Inc / 12,044 Bottles | Class II | Terminated |
| D-0361-2023 | 02-22-2023 | Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10. | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 24,870 vials | Class II | Terminated |
| D-0358-2023 | 02-22-2023 | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25. | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 270,291 bottles | Class II | Terminated |
| D-0359-2023 | 02-22-2023 | Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-302-10. | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 546,450 vials | Class II | Terminated |
| D-0357-2023 | 02-22-2023 | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25. | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 305,895 bottles | Class II | Terminated |
| D-0362-2023 | 02-22-2023 | Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25. | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 10,980 bottles | Class II | Terminated |
| D-0356-2023 | 02-22-2023 | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25. | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 443,483 bottles | Class II | Terminated |
| D-0360-2023 | 02-22-2023 | Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10. | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 31,500 vials | Class II | Terminated |
| D-0355-2023 | 02-22-2023 | Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15. | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 4,743 bottles | Class II | Terminated |
| D-0464-2023 | 02-21-2023 | Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27 Package NDCs: 0574-2067-27; 0574-2067-00 | Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point. | Padagis US LLC / 43,238 cartons | Class III | Ongoing |
| D-0444-2023 | 02-21-2023 | Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82 | CGMP DEVIATIONS | Denver Solutions, LLC DBA Leiters Health / 1212 units | Class II | Terminated |
| D-0443-2023 | 02-21-2023 | Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15 | CGMP DEVIATIONS | Denver Solutions, LLC DBA Leiters Health / 325,300 units | Class II | Terminated |
| D-0442-2023 | 02-21-2023 | Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11 | CGMP DEVIATIONS | Denver Solutions, LLC DBA Leiters Health / 13,445 units | Class II | Terminated |
| D-0445-2023 | 02-21-2023 | Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94 | CGMP DEVIATIONS | Denver Solutions, LLC DBA Leiters Health / 8,136 units | Class II | Terminated |
| D-0454-2023 | 02-17-2023 | DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1 Package NDCs: 71399-2829-1; 71399-2829-2 | Labeling: Incorrect or Missing Lot and/or Exp Date | Akron Pharma, Inc. / 4,416 tubes | Class III | Terminated |
| D-0354-2023 | 02-17-2023 | Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05. Package NDCs: 50228-177-30; 50228-177-01; 50228-177-05; 50228-178-30; 50228-178-01; 50228-178-05 | Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles. | Sciegen Pharmaceuticals Inc / 4,392 bottles | Class III | Terminated |
| D-0348-2023 | 02-15-2023 | Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01 | Failed Impurities/Degradation Specifications | RISING PHARMACEUTICALS / 12,216 bottles (100 count each) | Class II | Terminated |
| D-0489-2023 | 02-15-2023 | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328. Package NDCs: 52536-625-01; 52536-625-10 | cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. | Azurity Pharmaceuticals, Inc. / a) 16,471 vials; b) 43,096 vials | Class II | Terminated |
| D-0466-2023 | 02-15-2023 | Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7079-05 | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint. | AVEVA Drug Delivery Systems, Inc. / 5,208 cartons | Class III | Terminated |
| D-0465-2023 | 02-15-2023 | Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05 | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint. | AVEVA Drug Delivery Systems, Inc. / 11,520 cartons | Class III | Terminated |
| D-0456-2023 | 02-14-2023 | Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ. | Non-Sterility | Pharmedica USA, LLC / a) 869 bottles; b) 1035 bottles | Class I | Ongoing |
| D-0455-2023 | 02-14-2023 | Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04. | Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits. | Nanomaterials Discovery Corporation / 500 bottles | Class I | Ongoing |
| D-0457-2023 | 02-14-2023 | Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5 | CGMP Deviations | Pharmedica USA, LLC / 995 bottles | Class II | Ongoing |
| D-0453-2023 | 02-13-2023 | PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1. | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Volt Candy Wholesale Club / 432 capsules | Class I | Terminated |
| D-0346-2023 | 02-10-2023 | 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00 Package NDCs: 0264-5802-00; 0264-5802-10; 0264-5804-00; 0061786962; 0061797767; 0061797768; 0061787769; 0061797770; 0061797771; 0061797772; 0061797773; 0061797774; 0061797775; 0061797776; 0061812946; 0061812947; 0061812948; 0061812949; 0061812950; 0061816017; 0061816018; 0061816019; 0061816020; 0061816021; 0061816358; 0061816359; 0061816361; 0061816362; 0061816363; 0061816364; 0061818516; 0061818517; 0061818518; 0061821562; 0061821563; 0061821564; 0061823709; 0061823710; 0061823711; 0061823714; 0061823715; 0061823716; 0061824770; 0061824771; 0061824772; 0061824773; 0061824774; 0061824775; 0061824776; 0061824777; 0061826486; 0061826487; 0061826488 | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product. | B. Braun Medical Inc. / 1,343,982 bags | Class II | Completed |
| D-0347-2023 | 02-10-2023 | 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10 Package NDCs: 0264-5802-00; 0264-5802-10; 0264-5804-00; 0061794230; 0061794232; 0061797779; 0061797780; 0061797781; 0061797783; 0061797784; 0061797785; 0061797786; 0061797787; 0061797788; 0061809680 | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product. | B. Braun Medical Inc. / 483,229 bags | Class II | Completed |
| D-0908-2023 | 02-09-2023 | Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010. Package NDCs: 0113-0847-39; 0113-0847-95; 0113-0847-22; 0113-0847-00; 0113-0847-47 | Failed Impurities/Degradation Specifications | L. Perrigo Company / 32,376 cartons | Class II | Terminated |
| D-0910-2023 | 02-09-2023 | allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403. | Failed Impurities/Degradation Specifications | L. Perrigo Company / 208,416 cartons | Class II | Terminated |
| D-0904-2023 | 02-09-2023 | aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Perrigo Company, Allegan, MI USA 49010. NDC 55301-847-39 Package NDCs: 55301-847-39 | Failed Impurities/Degradation Specifications | L. Perrigo Company / 1,920 cartons | Class II | Terminated |
| D-0911-2023 | 02-09-2023 | Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 10001. NDC 45 tablets: 80159-112-03 | Failed Impurities/Degradation Specifications | L. Perrigo Company / 6,216 cartons | Class II | Terminated |
| D-0902-2023 | 02-09-2023 | Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, Salisbury, NC 28147. NDC 72476-847-22 Package NDCs: 72476-847-22; 72476-847-39; 72476-847-95 | Failed Impurities/Degradation Specifications | L. Perrigo Company / 3,240 cartons | Class II | Terminated |
| D-0901-2023 | 02-09-2023 | Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale Club, 25 Research Drive, Westborough, MA 01581. NDC 68391-847-47 Package NDCs: 68391-847-47; 68391-847-48 | Failed Impurities/Degradation Specifications | L. Perrigo Company / 23,868 cartons | Class II | Terminated |
| D-0912-2023 | 02-09-2023 | Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007. Package NDCs: 36800-691-13; 36800-691-39; 36800-691-22; 36800-691-49; 36800-691-95; 36800-691-75 | Failed Impurities/Degradation Specifications | L. Perrigo Company / 44,280 cartons | Class II | Terminated |
| D-0906-2023 | 02-09-2023 | allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. Package NDCs: 79481-0847-1; 79481-0847-0; 79481-0847-2; 79481-0847-4; 79481-0847-3 | Failed Impurities/Degradation Specifications | L. Perrigo Company / 59,688 cartons | Class II | Terminated |
| D-0271-2023 | 02-09-2023 | Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.dermalsource.com, 1-866-568-3223, NDC code: 80069-012-01, Drug Facts- For use by licensed professionals only' Active Ingredients- Lidocaine HCL (5%), Epinephrine (0.01%). | cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. | HTO Nevada, Inc. / 1,571 bottles | Class II | Terminated |
| D-0270-2023 | 02-09-2023 | New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by Dermal Source, Portland, OR, www.dermalsource.com 1-888-568-3223. NDC Code: 80069-008-01. Drug Facts- For use by licensed professionals only, Active Ingredients -Lidocaine HCL (5%), Tetracaine HCL (1%) and epinephrine (0.1%). | cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. | HTO Nevada, Inc. / 4709 bottles | Class II | Terminated |
| D-0905-2023 | 02-09-2023 | Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave., Allegan, MI 49010 USA. NDC 63981-847-48 Package NDCs: 63981-847-48 | Failed Impurities/Degradation Specifications | L. Perrigo Company / 360,184 | Class II | Terminated |
| D-0909-2023 | 02-09-2023 | allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811. Package NDCs: 56062-847-22; 56062-847-39; 56062-847-95 | Failed Impurities/Degradation Specifications | L. Perrigo Company / 32,904 cartons | Class II | Terminated |
| D-0903-2023 | 02-09-2023 | Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39 | Failed Impurities/Degradation Specifications | L. Perrigo Company / 16,200 cartons | Class II | Terminated |
| D-0907-2023 | 02-09-2023 | Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78 Package NDCs: 45802-847-78 | Failed Impurities/Degradation Specifications | L. Perrigo Company / 15,504 cartons | Class II | Terminated |
| D-0900-2023 | 02-09-2023 | Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count cartons (NDC 72288-847-47 and 72288-847-37), Distributed By: Amazon.com Services LLC., 410 Terry Avenue N., Seattle, WA 98109. Package NDCs: 72288-847-39; 72288-847-47; 72288-847-37 | Failed Impurities/Degradation Specifications | L. Perrigo Company / 11,904 cartons | Class II | Terminated |
| D-0330-2023 | 02-08-2023 | Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01. Package NDCs: 55111-525-30; 55111-525-01; 55111-525-05; 55111-525-79; 55111-525-78; 55111-526-30; 55111-526-01; 55111-526-05; 55111-526-79; 55111-526-78; 55111-527-30; 55111-527-01; 55111-527-05; 55111-527-79; 55111-527-78 | Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules. | Dr. Reddy's Laboratories, Inc. / 4,320 bottles | Class II | Ongoing |
