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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
| D-0487-2023 | 02-08-2023 | Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25 | Lack of assurance of sterility: Suspected microbial growth present on external label packaging. | Apollo Care / 215 bags | Class II | Ongoing |
| D-0403-2023 | 02-07-2023 | Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; NDC 16729-466-03, UPC 3 16729 46603 5 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 37,691 vials | Class II | Terminated |
| D-0400-2023 | 02-07-2023 | Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3; c) 1,000-count bottle NDC 16729-119-17 UPC 3 16729 11917 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA Package NDCs: 16729-119-10; 16729-119-15; 16729-119-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 665,469 bottles | Class II | Terminated |
| D-0413-2023 | 02-07-2023 | Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC 16729-493-45, UPC 3 16729 49345 1. | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 48,089 cartons | Class II | Terminated |
| D-0401-2023 | 02-07-2023 | Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-464-63, UPC 3 16729 46463 5; Carton NDC 16729-464-08, UPC 3 16729 46408 6 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 9,888 vials | Class II | Terminated |
| D-0402-2023 | 02-07-2023 | Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-465-31, UPC 3 16729 46531 1; Carton NDC 16729-465-03, UPC 3 16729 46503 8 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 5,090 vials | Class II | Terminated |
| D-0380-2023 | 02-07-2023 | Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 1,420,988 bottles | Class II | Terminated |
| D-0389-2023 | 02-07-2023 | Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets NDC 16729-415-17 UPC 3 16729 41517 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA Package NDCs: 16729-414-01; 16729-414-17; 16729-211-01; 16729-211-17; 16729-213-01; 16729-213-17; 16729-415-01; 16729-415-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 31,116 bottles | Class II | Terminated |
| D-0386-2023 | 02-07-2023 | Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-count bottle NDC 16729-211-17 UPC 3 16729 21117 8; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA Package NDCs: 16729-414-01; 16729-414-17; 16729-211-01; 16729-211-17; 16729-213-01; 16729-213-17; 16729-415-01; 16729-415-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 44,068 bottles | Class II | Terminated |
| D-0387-2023 | 02-07-2023 | Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-count NDC 16729-414-17 UPC 3 16729 41417 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA Package NDCs: 16729-414-01; 16729-414-17; 16729-211-01; 16729-211-17; 16729-213-01; 16729-213-17; 16729-415-01; 16729-415-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 69,122 bottles | Class II | Terminated |
| D-0418-2023 | 02-07-2023 | Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Packet NDC 16729-521-63, UPC 3 16729 52163 5; Carton NDC 16729-521-11, UPC 3 16729 52111 6. | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 821 cartons | Class II | Terminated |
| D-0419-2023 | 02-07-2023 | Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Bottle NDC 16729-467-15, UPC 3 16729 46715 5; Carton NDC 16729-467-85, UPC 3 16729 46785 8. Package NDCs: 16729-468-15; 16729-468-64; 16729-467-15; 16729-467-85; 16729-467-64 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 2614 cartons | Class II | Terminated |
| D-0417-2023 | 02-07-2023 | Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA Package NDCs: 16729-370-10; 16729-370-15; 16729-370-16; 16729-370-17; 16729-370-97; 16729-369-10; 16729-369-15; 16729-369-16; 16729-369-17; 16729-369-97; 16729-371-10; 16729-371-15; 16729-371-16; 16729-371-17; 16729-372-10; 16729-372-15; 16729-372-16; 16729-372-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 613,553 bottles | Class II | Terminated |
| D-0414-2023 | 02-07-2023 | Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA Package NDCs: 16729-370-10; 16729-370-15; 16729-370-16; 16729-370-17; 16729-370-97; 16729-369-10; 16729-369-15; 16729-369-16; 16729-369-17; 16729-369-97; 16729-371-10; 16729-371-15; 16729-371-16; 16729-371-17; 16729-372-10; 16729-372-15; 16729-372-16; 16729-372-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 36,773 bottles | Class II | Terminated |
| D-0369-2023 | 02-07-2023 | Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100-count bottle, NDC 16729-282-01, UPC 3 16729 28201 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India Package NDCs: 16729-278-10; 16729-278-01; 16729-278-16; 16729-278-46; 16729-279-10; 16729-279-01; 16729-279-16; 16729-279-46; 16729-280-10; 16729-280-01; 16729-280-16; 16729-280-46; 16729-281-10; 16729-281-01; 16729-281-16; 16729-281-46; 16729-282-10; 16729-282-01; 16729-282-16; 16729-282-46; 16729-283-10; 16729-283-01; 16729-283-16; 16729-283-46 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 170,448 bottles | Class II | Terminated |
| D-0368-2023 | 02-07-2023 | Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 16729-281-01, UPC 3 16729 28101 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India Package NDCs: 16729-278-10; 16729-278-01; 16729-278-16; 16729-278-46; 16729-279-10; 16729-279-01; 16729-279-16; 16729-279-46; 16729-280-10; 16729-280-01; 16729-280-16; 16729-280-46; 16729-281-10; 16729-281-01; 16729-281-16; 16729-281-46; 16729-282-10; 16729-282-01; 16729-282-16; 16729-282-46; 16729-283-10; 16729-283-01; 16729-283-16; 16729-283-46 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 312,864 bottles | Class II | Terminated |
| D-0379-2023 | 02-07-2023 | BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-289-12 UPC 3 16729 28912 2 Package NDCs: 16729-203-12; 16729-203-01; 16729-203-59; 16729-203-16; 16729-203-17; 16729-289-12; 16729-289-01; 16729-289-59; 16729-289-16; 16729-289-17; 16729-200-01; 16729-200-16; 16729-200-17; 16729-201-01; 16729-201-16; 16729-201-17; 16729-202-01; 16729-202-16; 16729-202-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 25,812 bottles | Class II | Terminated |
| D-0411-2023 | 02-07-2023 | Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets NDC 16729-006-17, UPC 3 16729 00617 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA Package NDCs: 16729-005-10; 16729-005-12; 16729-005-15; 16729-005-17; 16729-006-10; 16729-006-12; 16729-006-15; 16729-006-17; 16729-007-10; 16729-007-12; 16729-007-15; 16729-007-17; 16729-156-10; 16729-156-15; 16729-156-17; 16729-004-10; 16729-004-12; 16729-004-15; 16729-004-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 1,190,484 bottles | Class II | Terminated |
| D-0422-2023 | 02-07-2023 | Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-009-15, UPC 3 16729 00915 7. Package NDCs: 16729-008-15; 16729-008-16; 16729-008-17; 16729-009-15; 16729-009-16; 16729-009-17; 16729-010-15; 16729-010-16; 16729-010-17; 16729-011-15; 16729-011-16; 16729-011-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 32,688 bottles | Class II | Terminated |
| D-0367-2023 | 02-07-2023 | Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count bottle, NDC 16729-280-01, UPC 3 16729 28001 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India Package NDCs: 16729-278-10; 16729-278-01; 16729-278-16; 16729-278-46; 16729-279-10; 16729-279-01; 16729-279-16; 16729-279-46; 16729-280-10; 16729-280-01; 16729-280-16; 16729-280-46; 16729-281-10; 16729-281-01; 16729-281-16; 16729-281-46; 16729-282-10; 16729-282-01; 16729-282-16; 16729-282-46; 16729-283-10; 16729-283-01; 16729-283-16; 16729-283-46 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 539,004 bottles | Class II | Terminated |
| D-0409-2023 | 02-07-2023 | Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count bottle NDC 16729-004-17, UPC 3 16729 00417 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA Package NDCs: 16729-005-10; 16729-005-12; 16729-005-15; 16729-005-17; 16729-006-10; 16729-006-12; 16729-006-15; 16729-006-17; 16729-007-10; 16729-007-12; 16729-007-15; 16729-007-17; 16729-156-10; 16729-156-15; 16729-156-17; 16729-004-10; 16729-004-12; 16729-004-15; 16729-004-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 291,378 bottles | Class II | Terminated |
| D-0383-2023 | 02-07-2023 | Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-490-12 UPC 3 16729 49012 2 Package NDCs: 16729-490-12; 16729-490-59; 16729-491-12; 16729-491-59; 16729-492-12; 16729-492-59 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 37,790 bottles | Class II | Terminated |
| D-0381-2023 | 02-07-2023 | Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) 10 Single-dose vials NDC 16729-434-45 UPC 3 16729 43445 4 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA Package NDCs: 16729-434-05; 16729-434-45 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 65,233 vials | Class II | Terminated |
| D-0408-2023 | 02-07-2023 | Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-count bottle NDC 16729-156-17, UPC 3 16729 15617 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA Package NDCs: 16729-005-10; 16729-005-12; 16729-005-15; 16729-005-17; 16729-006-10; 16729-006-12; 16729-006-15; 16729-006-17; 16729-007-10; 16729-007-12; 16729-007-15; 16729-007-17; 16729-156-10; 16729-156-15; 16729-156-17; 16729-004-10; 16729-004-12; 16729-004-15; 16729-004-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 256,648 bottles | Class II | Terminated |
| D-0407-2023 | 02-07-2023 | Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-count bottle NDC 16729-287-15, UPC 3 16729 28715 9; c) 1,000-count bottle NDC 16729-287-17, UPC 3 16729 28717 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA Package NDCs: 16729-284-10; 16729-284-15; 16729-284-17; 16729-285-10; 16729-285-15; 16729-285-17; 16729-286-10; 16729-286-15; 16729-286-17; 16729-287-10; 16729-287-15; 16729-287-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 102,360 bottles | Class II | Terminated |
| D-0395-2023 | 02-07-2023 | Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-count NDC 16729-003-16 UPC 3 16729 00316 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA Package NDCs: 16729-001-01; 16729-001-16; 16729-001-17; 16729-002-01; 16729-002-16; 16729-002-17; 16729-003-01; 16729-003-16; 16729-003-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 1,158,839 bottles | Class II | Terminated |
| D-0374-2023 | 02-07-2023 | Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA Package NDCs: 16729-045-10; 16729-045-15; 16729-045-01; 16729-045-16; 16729-045-17; 16729-044-10; 16729-044-15; 16729-044-01; 16729-044-16; 16729-044-17; 16729-046-10; 16729-046-15; 16729-046-01; 16729-046-16; 16729-046-17; 16729-047-10; 16729-047-15; 16729-047-01; 16729-047-16; 16729-047-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 72,376 bottles | Class II | Terminated |
| D-0410-2023 | 02-07-2023 | Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-count bottle NDC 16729-005-17, UPC 3 16729 00517 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA Package NDCs: 16729-005-10; 16729-005-12; 16729-005-15; 16729-005-17; 16729-006-10; 16729-006-12; 16729-006-15; 16729-006-17; 16729-007-10; 16729-007-12; 16729-007-15; 16729-007-17; 16729-156-10; 16729-156-15; 16729-156-17; 16729-004-10; 16729-004-12; 16729-004-15; 16729-004-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 1,394,208 bottles | Class II | Terminated |
| D-0376-2023 | 02-07-2023 | BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) 500 Tablets NDC 16729-200-16 UPC 3 16729 20016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA Package NDCs: 16729-203-12; 16729-203-01; 16729-203-59; 16729-203-16; 16729-203-17; 16729-289-12; 16729-289-01; 16729-289-59; 16729-289-16; 16729-289-17; 16729-200-01; 16729-200-16; 16729-200-17; 16729-201-01; 16729-201-16; 16729-201-17; 16729-202-01; 16729-202-16; 16729-202-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 24,408 bottles | Class II | Terminated |
| D-0399-2023 | 02-07-2023 | Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 20mL vial NDC 16729-474-05 UPC 3 16729 47405 4;carton NDC 16729-474-03 UPC 3 16729 47403 0 Package NDCs: 16729-471-08; 16729-472-08; 16729-473-03; 16729-474-03; 16729-474-05 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 322 vials | Class II | Terminated |
| D-0365-2023 | 02-07-2023 | Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-count bottle, NDC 16729-278-01, UPC 3 16729 27801 10 Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India Package NDCs: 16729-278-10; 16729-278-01; 16729-278-16; 16729-278-46; 16729-279-10; 16729-279-01; 16729-279-16; 16729-279-46; 16729-280-10; 16729-280-01; 16729-280-16; 16729-280-46; 16729-281-10; 16729-281-01; 16729-281-16; 16729-281-46; 16729-282-10; 16729-282-01; 16729-282-16; 16729-282-46; 16729-283-10; 16729-283-01; 16729-283-16; 16729-283-46 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 747,464 bottles | Class II | Terminated |
| D-0405-2023 | 02-07-2023 | Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) 1,000-count bottle NDC 16729-285-17, UPC 3 16729 28517 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA Package NDCs: 16729-284-10; 16729-284-15; 16729-284-17; 16729-285-10; 16729-285-15; 16729-285-17; 16729-286-10; 16729-286-15; 16729-286-17; 16729-287-10; 16729-287-15; 16729-287-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 56,862 bottles | Class II | Terminated |
| D-0415-2023 | 02-07-2023 | Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 16729-370-16, UPC 3 16729 37016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA Package NDCs: 16729-370-10; 16729-370-15; 16729-370-16; 16729-370-17; 16729-370-97; 16729-369-10; 16729-369-15; 16729-369-16; 16729-369-17; 16729-369-97; 16729-371-10; 16729-371-15; 16729-371-16; 16729-371-17; 16729-372-10; 16729-372-15; 16729-372-16; 16729-372-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 1,113,264 bottles | Class II | Terminated |
| D-0391-2023 | 02-07-2023 | Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 71713-096-90 UPC 3 71713 09690 2 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 1,440,652 bottles | Class II | Terminated |
| D-0392-2023 | 02-07-2023 | Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-count bottles NDC 16729-090-15 UPC 3 16729 09015 5; c) 100-count bottles NDC 16729-090-01 UPC 3 16729 09001 8; d) 500-count bottles NDC 16729-090-16 UPC 3 16729 09016 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA Package NDCs: 16729-090-10; 16729-090-15; 16729-090-01; 16729-090-16; 16729-090-17 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 2,731,365 bottles | Class II | Terminated |
| D-0390-2023 | 02-07-2023 | Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-count bottle NDC 16729-089-15 UPC 3 16729 08915 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA Package NDCs: 16729-089-10; 16729-089-15 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 325,356 bottles | Class II | Terminated |
| D-0426-2023 | 02-07-2023 | rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-233-01, UPC 3 16729 23301 9 Package NDCs: 16729-232-01; 16729-233-01; 16729-234-01; 16729-235-01; 16729-236-01; 16729-237-01; 16729-238-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 181,848 bottles | Class II | Terminated |
| D-0428-2023 | 02-07-2023 | rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-235-01, UPC 3 16729 23501 3 Package NDCs: 16729-232-01; 16729-233-01; 16729-234-01; 16729-235-01; 16729-236-01; 16729-237-01; 16729-238-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 25,344 bottles | Class II | Terminated |
| D-0427-2023 | 02-07-2023 | rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-234-01, UPC 3 16729 23401 6 Package NDCs: 16729-232-01; 16729-233-01; 16729-234-01; 16729-235-01; 16729-236-01; 16729-237-01; 16729-238-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 104,945 bottles | Class II | Terminated |
| D-0425-2023 | 02-07-2023 | rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-232-01, UPC 3 16729 23201 2; Package NDCs: 16729-232-01; 16729-233-01; 16729-234-01; 16729-235-01; 16729-236-01; 16729-237-01; 16729-238-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 139,332 bottles | Class II | Terminated |
| D-0431-2023 | 02-07-2023 | rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-238-01, UPC 3 16729 23801 4 Package NDCs: 16729-232-01; 16729-233-01; 16729-234-01; 16729-235-01; 16729-236-01; 16729-237-01; 16729-238-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 5,112 bottles | Class II | Terminated |
| D-0429-2023 | 02-07-2023 | rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-236-01, UPC 3 16729 23601 0 Package NDCs: 16729-232-01; 16729-233-01; 16729-234-01; 16729-235-01; 16729-236-01; 16729-237-01; 16729-238-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. / 14,928 bottles | Class II | Terminated |
