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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |
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. | Completed |