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- Recall Enforcement Event ID: 89450
Recall Enforment Report D-0194-2024
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by CARDINAL HEALTHCARE, originally initiated on 01-26-2022 for the product Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1 The product was recalled due to cgmp deviations: products were exposed to temperatures outside of the products labeled storage conditions.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
---|---|---|---|---|---|---|---|
D-0194-2024 | 01-26-2022 | 01-03-2024 | Class II | 2 units | Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0200-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0162-2024 | 01-26-2022 | 01-03-2024 | Class II | 2 cartons | ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0190-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactured for: Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156. NDC: 69097-159-15 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0184-2024 | 01-26-2022 | 01-03-2024 | Class II | 2 units | HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. NDC: 23155-002-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0187-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0183-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0196-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0163-2024 | 01-26-2022 | 01-03-2024 | Class II | 11 cartons | ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India. NDC: 68180-963-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0180-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0166-2024 | 01-26-2022 | 01-03-2024 | Class II | 2 units | AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0177-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0189-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0199-2024 | 01-26-2022 | 01-03-2024 | Class II | 2 units | Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0181-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0191-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0182-2024 | 01-26-2022 | 01-03-2024 | Class II | 6 units | Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0178-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA. NDC 68180-652-08 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0192-2024 | 01-26-2022 | 01-03-2024 | Class II | 2 units | Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447. | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0174-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0193-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0161-2024 | 01-26-2022 | 01-03-2024 | Class II | 2 cartons | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0175-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0171-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0172-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC: 43598-719-10 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0168-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ 07940. NDC: 0456-0461-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0176-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-276-09 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0198-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713-0552-73 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0173-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 0378-6232-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0169-2024 | 01-26-2022 | 01-03-2024 | Class II | 3 units | Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore. NDC: 78206-114-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0164-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106. NDC: 55111-730-05 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0195-2024 | 01-26-2022 | 01-03-2024 | Class II | 2 units | Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switzerland; Distributed by: Ricola USA Inc., 6 Campus Drive, 2nd Floor South, Parsippany, NJ 07054. NDC: 54305-507-10 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0197-2024 | 01-26-2022 | 01-03-2024 | Class II | 5 units | SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0201-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0179-2024 | 01-26-2022 | 01-03-2024 | Class II | 2 units | Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0170-2024 | 01-26-2022 | 01-03-2024 | Class II | 2 units | Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0185-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0186-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0167-2024 | 01-26-2022 | 01-03-2024 | Class II | 2 units | Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0165-2024 | 01-26-2022 | 01-03-2024 | Class II | 3 units | AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0188-2024 | 01-26-2022 | 01-03-2024 | Class II | 2 units | Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
D-0202-2024 | 01-26-2022 | 01-03-2024 | Class II | 1 unit | Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | Terminated |
Recalled Products
NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
---|---|---|---|---|---|---|
0093-1712 | Warfarin Sodium | Teva Pharmaceuticals Usa, Inc. | ||||
0093-1712 | Warfarin Sodium | Warfarin Sodium | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-1713 | Warfarin Sodium | Teva Pharmaceuticals Usa, Inc. | ||||
0093-1713 | Warfarin Sodium | Warfarin Sodium | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-1714 | Warfarin Sodium | Teva Pharmaceuticals Usa, Inc. | ||||
0093-1714 | Warfarin Sodium | Warfarin Sodium | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-1715 | Warfarin Sodium | Teva Pharmaceuticals Usa, Inc. | ||||
0093-1715 | Warfarin Sodium | Warfarin Sodium | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-1716 | Warfarin Sodium | Teva Pharmaceuticals Usa, Inc. | ||||
0093-1716 | Warfarin Sodium | Warfarin Sodium | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-1718 | Warfarin Sodium | Teva Pharmaceuticals Usa, Inc. | ||||
0093-1718 | Warfarin Sodium | Warfarin Sodium | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-1720 | Warfarin Sodium | Teva Pharmaceuticals Usa, Inc. | ||||
0093-1720 | Warfarin Sodium | Warfarin Sodium | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-1721 | Warfarin Sodium | Teva Pharmaceuticals Usa, Inc. | ||||
0093-1721 | Warfarin Sodium | Warfarin Sodium | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-1723 | Warfarin Sodium | Teva Pharmaceuticals Usa, Inc. | ||||
0093-1723 | Warfarin Sodium | Warfarin Sodium | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-2263 | Amoxicillin | Teva Pharmaceuticals Usa, Inc. | ||||
0093-2263 | Amoxicillin | Amoxicillin | Tablet, Film Coated | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-2264 | Amoxicillin | Teva Pharmaceuticals Usa, Inc. | ||||
0093-2264 | Amoxicillin | Amoxicillin | Tablet, Film Coated | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-2267 | Amoxicillin | Amoxicillin | Tablet, Chewable | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-2268 | Amoxicillin | Amoxicillin | Tablet, Chewable | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-3107 | Amoxicillin | Amoxicillin | Capsule | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-3109 | Amoxicillin | Amoxicillin | Capsule | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-4155 | Amoxicillin | Amoxicillin | Powder, For Suspension | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-4160 | Amoxicillin | Teva Pharmaceuticals Usa, Inc. | ||||
0093-4160 | Amoxicillin | Amoxicillin | Powder, For Suspension | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0093-4161 | Amoxicillin | Teva Pharmaceuticals Usa, Inc. | ||||
0093-4161 | Amoxicillin | Amoxicillin | Powder, For Suspension | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0378-1300 | Lithium Carbonate | Mylan Pharmaceuticals Inc. | ||||
0378-6231 | Citalopram | Citalopram | Tablet, Film Coated | Oral | Mylan Pharmaceuticals Inc. | Human Prescription Drug |
0378-6232 | Citalopram | Citalopram | Tablet, Film Coated | Oral | Mylan Pharmaceuticals Inc. | Human Prescription Drug |
0378-6233 | Citalopram | Citalopram | Tablet, Film Coated | Oral | Mylan Pharmaceuticals Inc. | Human Prescription Drug |
0378-9320 | Wixela Inhub | Fluticasone Propionate And Salmeterol | Powder | Respiratory (inhalation) | Mylan Pharmaceuticals Inc. | Human Prescription Drug |
0378-9321 | Wixela Inhub | Fluticasone Propionate And Salmeterol | Powder | Respiratory (inhalation) | Mylan Pharmaceuticals Inc. | Human Prescription Drug |
0378-9322 | Wixela Inhub | Fluticasone Propionate And Salmeterol | Powder | Respiratory (inhalation) | Mylan Pharmaceuticals Inc. | Human Prescription Drug |
0456-0457 | Armour Thyroid | Thyroid, Porcine | Tablet | Oral | Allergan, Inc. | Human Prescription Drug |
0456-0458 | Armour Thyroid | Thyroid, Porcine | Tablet | Oral | Allergan, Inc. | Human Prescription Drug |
0456-0459 | Armour Thyroid | Thyroid, Porcine | Tablet | Oral | Allergan, Inc. | Human Prescription Drug |
0456-0460 | Armour Thyroid | Thyroid, Porcine | Tablet | Oral | Allergan, Inc. | Human Prescription Drug |
0456-0461 | Armour Thyroid | Thyroid, Porcine | Tablet | Oral | Allergan, Inc. | Human Prescription Drug |
0456-0462 | Armour Thyroid | Thyroid, Porcine | Tablet | Oral | Allergan, Inc. | Human Prescription Drug |
0456-0463 | Armour Thyroid | Thyroid, Porcine | Tablet | Oral | Allergan, Inc. | Human Prescription Drug |
0456-0464 | Armour Thyroid | Thyroid, Porcine | Tablet | Oral | Allergan, Inc. | Human Prescription Drug |
0456-1045 | Armour Thyroid | Thyroid, Porcine | Tablet | Oral | Allergan, Inc. | Human Prescription Drug |
0536-1234 | Aspirin Low Dose | Aspirin | Tablet, Delayed Release | Oral | Rugby Laboratories | Human Otc Drug |
0555-0886 | Estradiol | Estradiol | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0555-0887 | Estradiol | Estradiol | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0555-0899 | Estradiol | Estradiol | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0591-0794 | Dicyclomine Hydrochloride | Capsule | Actavis Pharma, Inc. | Drug For Further Processing | ||
0591-0794 | Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | Capsule | Oral | Actavis Pharma, Inc. | Human Prescription Drug |
0591-0795 | Dicyclomine Hydrochloride | Tablet | Actavis Pharma, Inc. | Drug For Further Processing | ||
0591-0795 | Dicyclomine Hydrochloride | Dicyclomine Hydrochloride | Tablet | Oral | Actavis Pharma, Inc. | Human Prescription Drug |
0597-0075 | Spiriva HandiHaler | Tiotropium Bromide | Capsule | Oral; Respiratory (inhalation) | Boehringer Ingelheim Pharmaceuticals, Inc. | Human Prescription Drug |
0597-0152 | Jardiance | Empagliflozin | Tablet, Film Coated | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. | Human Prescription Drug |
0597-0153 | Jardiance | Empagliflozin | Tablet, Film Coated | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. | Human Prescription Drug |
0713-0552 | Terconazole | Terconazole | Suppository | Vaginal | Cosette Pharmaceuticals, Inc. | Human Prescription Drug |
0781-2020 | Amoxicillin | Amoxicillin | Capsule | Oral | Sandoz Inc | Human Prescription Drug |
0781-2613 | Amoxicillin | Amoxicillin | Capsule | Oral | Sandoz Inc | Human Prescription Drug |
0781-3238 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Sandoz Inc | Human Prescription Drug |
0781-3246 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Sandoz Inc | Human Prescription Drug |
0781-3256 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Sandoz Inc | Human Prescription Drug |
0781-3262 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Sandoz Inc | Human Prescription Drug |
0781-3268 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Sandoz Inc | Human Prescription Drug |
0781-3298 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Sandoz Inc | Human Prescription Drug |
0781-3299 | Enoxaparin Sodium | Enoxaparin Sodium | Injection | Subcutaneous | Sandoz Inc | Human Prescription Drug |
0781-5060 | Amoxicillin | Sandoz Inc | ||||
0781-5061 | Amoxicillin | Amoxicillin | Tablet, Film Coated | Oral | Sandoz Inc | Human Prescription Drug |
0781-6039 | Amoxicillin | Amoxicillin | Powder, For Suspension | Oral | Sandoz Inc | Human Prescription Drug |
0781-6041 | Amoxicillin | Amoxicillin | Powder, For Suspension | Oral | Sandoz Inc | Human Prescription Drug |
0781-6156 | Amoxicillin | Amoxicillin | Powder, For Suspension | Oral | Sandoz Inc | Human Prescription Drug |
0781-6157 | Amoxicillin | Amoxicillin | Powder, For Suspension | Oral | Sandoz Inc | Human Prescription Drug |
23155-001 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Tablet, Film Coated | Oral | Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. | Human Prescription Drug |
23155-002 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Tablet, Film Coated | Oral | Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. | Human Prescription Drug |
23155-003 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Tablet, Film Coated | Oral | Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. | Human Prescription Drug |
23155-004 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Tablet, Film Coated | Oral | Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. | Human Prescription Drug |
43547-275 | Donepezil Hydrochloride | Donepezil Hydrochloride | Tablet, Film Coated | Oral | Solco Healthcare Us, Llc | Human Prescription Drug |
43547-276 | Donepezil Hydrochloride | Donepezil Hydrochloride | Tablet, Film Coated | Oral | Solco Healthcare Us, Llc | Human Prescription Drug |
43598-719 | Chlorthalidone | Chlorthalidone | Tablet | Oral | Dr. Reddy's Laboratories Inc. | Human Prescription Drug |
43598-720 | Chlorthalidone | Chlorthalidone | Tablet | Oral | Dr. Reddy's Laboratories Inc. | Human Prescription Drug |
45963-676 | Metoprolol Succinate | Tablet, Film Coated, Extended Release | Actavis Pharma, Inc. | Drug For Further Processing | ||
45963-676 | Metoprolol Succinate | Metoprolol Succinate | Tablet, Film Coated, Extended Release | Oral | Actavis Pharma, Inc. | Human Prescription Drug |
45963-677 | Metoprolol Succinate | Tablet, Film Coated, Extended Release | Actavis Pharma, Inc. | Drug For Further Processing | ||
45963-677 | Metoprolol Succinate | Metoprolol Succinate | Tablet, Film Coated, Extended Release | Oral | Actavis Pharma, Inc. | Human Prescription Drug |
45963-678 | Metoprolol Succinate | Tablet, Film Coated, Extended Release | Actavis Pharma, Inc. | Drug For Further Processing | ||
45963-678 | Metoprolol Succinate | Metoprolol Succinate | Tablet, Film Coated, Extended Release | Oral | Actavis Pharma, Inc. | Human Prescription Drug |
45963-709 | Metoprolol Succinate | Tablet, Film Coated, Extended Release | Actavis Pharma, Inc. | Drug For Further Processing | ||
45963-709 | Metoprolol Succinate | Metoprolol Succinate | Tablet, Film Coated, Extended Release | Oral | Actavis Pharma, Inc. | Human Prescription Drug |
54305-507 | Natural Cherry Honey Herb Throat Drops | Menthol | Lozenge | Oral | Ricola Ag | Human Otc Drug |
55111-729 | Allopurinol | Allopurinol | Tablet | Oral | Dr. Reddy's Laboratories Limited | Human Prescription Drug |
55111-730 | Allopurinol | Allopurinol | Tablet | Oral | Dr. Reddy's Laboratories Limited | Human Prescription Drug |
59746-172 | Prednisone | Prednisone | Tablet | Oral | Jubilant Cadista Pharmaceuticals Inc. | Human Prescription Drug |
59746-173 | Prednisone | Prednisone | Tablet | Oral | Jubilant Cadista Pharmaceuticals Inc. | Human Prescription Drug |
59746-175 | Prednisone | Prednisone | Tablet | Oral | Jubilant Cadista Pharmaceuticals Inc. | Human Prescription Drug |
59746-782 | Prednisone | Prednisone | Tablet | Oral | Jubilant Cadista Pharmaceuticals Inc. | Human Prescription Drug |
59746-783 | Prednisone | Prednisone | Tablet | Oral | Jubilant Cadista Pharmaceuticals Inc. | Human Prescription Drug |
60505-0829 | Fluticasone Propionate | Fluticasone Propionate | Spray, Metered | Nasal | Apotex Corp. | Human Prescription Drug |
65162-896 | Aripiprazole | Aripiprazole | Tablet | Oral | Amneal Pharmaceuticals Llc | Human Prescription Drug |
65162-897 | Aripiprazole | Aripiprazole | Tablet | Oral | Amneal Pharmaceuticals Llc | Human Prescription Drug |
65162-898 | Aripiprazole | Aripiprazole | Tablet | Oral | Amneal Pharmaceuticals Llc | Human Prescription Drug |
65162-899 | Aripiprazole | Aripiprazole | Tablet | Oral | Amneal Pharmaceuticals Llc | Human Prescription Drug |
65162-901 | Aripiprazole | Aripiprazole | Tablet | Oral | Amneal Pharmaceuticals Llc | Human Prescription Drug |
65162-902 | Aripiprazole | Aripiprazole | Tablet | Oral | Amneal Pharmaceuticals Llc | Human Prescription Drug |
66993-019 | Albuterol Sulfate HFA | Albuterol Sulfate | Aerosol, Metered | Respiratory (inhalation) | Prasco Laboratories | Human Prescription Drug |
68180-518 | Lisinopril And Hydrochlorothiazide | Lisinopril And Hydrochlorothiazide | Tablet | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-519 | Lisinopril And Hydrochlorothiazide | Lisinopril And Hydrochlorothiazide | Tablet | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-520 | Lisinopril And Hydrochlorothiazide | Lisinopril And Hydrochlorothiazide | Tablet | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-650 | Doxycycline | Doxycycline | Capsule | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-651 | Doxycycline | Lupin Pharmaceuticals, Inc. | ||||
68180-652 | Doxycycline | Doxycycline | Capsule | Oral | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
68180-963 | Albuterol Sulfate | Albuterol Sulfate | Aerosol, Metered | Respiratory (inhalation) | Lupin Pharmaceuticals, Inc. | Human Prescription Drug |
69097-158 | Meloxicam | Meloxicam | Tablet | Oral | Cipla Usa Inc. | Human Prescription Drug |
69097-159 | Meloxicam | Meloxicam | Tablet | Oral | Cipla Usa Inc. | Human Prescription Drug |
69097-840 | Ipratropium Bromide And Albuterol Sulfate | Ipratropium Bromide And Albuterol Sulfate | Solution | Respiratory (inhalation) | Cipla Usa Inc. | Human Prescription Drug |
69238-2077 | Propranolol Hydrochloride | Propranolol Hydrochloride | Tablet | Oral | Amneal Pharmaceuticals Ny Llc | Human Prescription Drug |
69238-2078 | Propranolol Hydrochloride | Propranolol Hydrochloride | Tablet | Oral | Amneal Pharmaceuticals Ny Llc | Human Prescription Drug |
69238-2079 | Propranolol Hydrochloride | Propranolol Hydrochloride | Tablet | Oral | Amneal Pharmaceuticals Ny Llc | Human Prescription Drug |
69238-2080 | Propranolol Hydrochloride | Propranolol Hydrochloride | Tablet | Oral | Amneal Pharmaceuticals Ny Llc | Human Prescription Drug |
69238-2081 | Propranolol Hydrochloride | Propranolol Hydrochloride | Tablet | Oral | Amneal Pharmaceuticals Ny Llc | Human Prescription Drug |
69315-127 | Folic Acid | Folic Acid | Tablet | Oral | Leading Pharma, Llc | Human Prescription Drug |
70000-0126 | Nasal Decongestant Pe Maximum Strength | Phenylephrine Hcl | Tablet, Film Coated | Oral | Cardinal Health 110, Llc. Dba Leader | Human Otc Drug |
78206-114 | Asmanex | Mometasone Furoate | Inhalant | Respiratory (inhalation) | Organon Llc | Human Prescription Drug |
78206-115 | Asmanex | Mometasone Furoate | Inhalant | Respiratory (inhalation) | Organon Llc | Human Prescription Drug |
Recall Enforcement Report D-0194-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0194-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 100023596 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 69238-2077-1; 69238-2077-7; 69238-2078-1; 69238-2078-7; 69238-2079-1; 69238-2079-7; 69238-2080-1; 69238-2081-1; 69238-2081-5
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0200-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0200-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 2169041 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0093-1712-01; 0093-1712-10; 0093-1713-01; 0093-1713-10; 0093-1714-01; 0093-1714-10; 0093-1715-01; 0093-1716-01; 0093-1716-10; 0093-1721-01; 0093-1721-10; 0093-1718-01; 0093-1723-01; 0093-1720-01
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0162-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0162-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 cartons Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch MY7E Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 66993-019-68
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0190-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0190-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactured for: Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156. NDC: 69097-159-15
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch KA11489 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 69097-158-15; 69097-158-07; 69097-158-12; 69097-159-12; 69097-159-07; 69097-159-15
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0184-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0184-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. NDC: 23155-002-01
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch G210553, G210551 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 23155-001-01; 23155-001-10; 23155-002-10; 23155-002-01; 23155-003-01; 23155-003-10; 23155-004-01; 23155-004-10
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0187-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0187-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch A5921 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0183-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0183-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch H08221 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 69315-127-01; 69315-127-10
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0196-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0196-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch P0248AL0AT Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0163-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0163-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India. NDC: 68180-963-01
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 11 cartons Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch K100715 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68180-963-01
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0180-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0180-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 100023687 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0555-0899-02; 0555-0886-02; 0555-0886-04; 0555-0887-02; 0555-0887-04
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0166-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0166-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch LJ9004 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0781-2020-31; 0781-2020-76; 0781-2020-01; 0781-2020-05; 0781-2613-31; 0781-2613-76; 0781-2613-01; 0781-2613-05; 0781-5060-20; 0781-5060-01; 0781-5061-20; 0781-5061-01; 0781-6039-58; 0781-6039-46; 0781-6039-55; 0781-6156-52; 0781-6156-57; 0781-6156-46; 0781-6041-58; 0781-6041-46; 0781-6041-55; 0781-6157-52; 0781-6157-57; 0781-6157-46
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0177-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0177-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 17605 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 43547-275-03; 43547-275-09; 43547-275-11; 43547-276-03; 43547-276-09; 43547-276-11
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0189-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0189-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 3138326 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-1300-01; 0378-1300-05
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0199-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0199-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 21000279A, 21000280A Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0181-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0181-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 21025A Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0191-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0191-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 2447J211 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 45963-709-96; 45963-709-11; 45963-676-11; 45963-676-96; 45963-677-96; 45963-677-11; 45963-678-11
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0182-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0182-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 6 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch TE9159, TE8156 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 60505-0829-1
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0178-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0178-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA. NDC 68180-652-08
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch G104819 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68180-650-01; 68180-651-01; 68180-652-29; 68180-652-08
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0192-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0192-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 400454 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0174-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0174-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 1293US561C Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0193-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0193-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 21P0659 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 59746-782-30; 59746-782-01; 59746-172-10; 59746-172-06; 59746-173-10; 59746-173-09; 59746-173-06; 59746-175-09; 59746-175-06; 59746-175-10; 59746-783-01
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0161-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0161-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 cartons Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 21C56 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 69097-840-34; 69097-840-53; 69097-840-87; 69097-840-64
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0175-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0175-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, Parsippany, NJ 07054. NDC: 0591-0795-01
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 3197790 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0591-0794-01; 0591-0794-10; 0591-0795-01; 0591-0795-10
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0171-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0171-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch AM211171 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0172-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0172-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854 USA; Manufactured For: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA. NDC: 43598-719-10
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 2107329UM Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 43598-719-01; 43598-719-10; 43598-720-01; 43598-720-10
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0168-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0168-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ 07940. NDC: 0456-0461-01
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch W05543 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0456-0457-01; 0456-1045-01; 0456-0458-01; 0456-0458-11; 0456-0458-63; 0456-0459-01; 0456-0459-11; 0456-0459-63; 0456-0460-01; 0456-0461-01; 0456-0461-11; 0456-0461-63; 0456-0462-01; 0456-0463-01; 0456-0464-01
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0176-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0176-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-276-09
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 17616 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 43547-275-03; 43547-275-09; 43547-275-11; 43547-276-03; 43547-276-09; 43547-276-11
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0198-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0198-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713-0552-73
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 1014228A Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0713-0552-73
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0173-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0173-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 0378-6232-01
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 3131748 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-6231-01; 0378-6231-05; 0378-6232-01; 0378-6232-05; 0378-6233-01; 0378-6233-05
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0169-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0169-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore. NDC: 78206-114-01
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch U027458 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 78206-114-03; 78206-114-04; 78206-114-02; 78206-114-01; 78206-114-59; 78206-115-59; 78206-115-01
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0164-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0164-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106. NDC: 55111-730-05
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch L100813 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 55111-729-01; 55111-729-10; 55111-730-01; 55111-730-05; 55111-730-10
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0195-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0195-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switzerland; Distributed by: Ricola USA Inc., 6 Campus Drive, 2nd Floor South, Parsippany, NJ 07054. NDC: 54305-507-10
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 2000058693 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 54305-507-10; 2000058693
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0197-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0197-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 104440 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0597-0075-41; 0597-0075-75; 0597-0075-47
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0201-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0201-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 2323041 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0093-1712-01; 0093-1712-10; 0093-1713-01; 0093-1713-10; 0093-1714-01; 0093-1714-10; 0093-1715-01; 0093-1716-01; 0093-1716-10; 0093-1721-01; 0093-1721-10; 0093-1718-01; 0093-1723-01; 0093-1720-01
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0179-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0179-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch SAH06821A Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0781-3238-01; 0781-3238-63; 0781-3246-02; 0781-3246-64; 0781-3256-03; 0781-3256-66; 0781-3262-04; 0781-3262-68; 0781-3268-05; 0781-3268-69; 0781-3298-04; 0781-3298-68; 0781-3299-05; 0781-3299-69
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0170-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0170-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch P126201 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0536-1234-41
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0185-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0185-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch D41919 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 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
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0186-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0186-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch P125514 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 70000-0126-1; 70000-0126-2
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0167-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0167-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch AR202318 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 65162-896-03; 65162-896-09; 65162-896-50; 65162-896-11; 65162-897-03; 65162-897-09; 65162-897-50; 65162-897-11; 65162-898-03; 65162-898-09; 65162-898-50; 65162-898-11; 65162-899-03; 65162-899-09; 65162-899-50; 65162-899-11; 65162-901-03; 65162-901-09; 65162-901-50; 65162-901-11; 65162-902-03; 65162-902-09; 65162-902-50; 65162-902-11
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0165-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0165-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 35447184A Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0093-2263-01; 0093-2264-01; 0093-4160-76; 0093-4160-78; 0093-4160-73; 0093-4155-79; 0093-4155-73; 0093-4155-80; 0093-4161-76; 0093-4161-78; 0093-4161-73; 0093-2267-01; 0093-2268-01; 0093-3107-01; 0093-3107-05; 0093-3109-53; 0093-3109-06; 0093-3109-01; 0093-3109-05
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0188-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0188-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2 units Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch Q101699, Q101981 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68180-518-02; 68180-518-01; 68180-518-30; 68180-519-30; 68180-519-01; 68180-519-02; 68180-520-02; 68180-520-30; 68180-520-01
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0202-2024
- Event ID
- 89450 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0202-2024 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32
- Reason For Recall
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1 unit Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 01-03-2024
- Recall Initiation Date
- 01-26-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 09-29-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- CARDINAL HEALTHCARE
- Code Info
- Batch 62002532 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-9320-32; 0378-9321-32; 0378-9322-32
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.