Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUP
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IINarcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal spray. 0.1 mL intranasal spray per unit For use in the nose only Rx only NDC 69547-353-02 Distributed by Adapt Pharma, Inc. Radnor, PA 19087 USA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIBanzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIIvermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4799-806-01 Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIPhenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIPREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIBENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIIron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIPrilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 Switzerland
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IICIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IINadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla USA Inc. 9100 S. Dadeland Blvd., Suite 1599 Miami, FL 33156
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIMeloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured for: Cipla USA, Inc. 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IISodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx Only NDC 50096-502-10 Manufactured for: Rosemar Labs, LLC 2100 West Loop South Suite 900 Houston, TX 77027
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIValsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIPRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IISynjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IISynjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIJentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IISynjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIGlyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597-0164-30 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IISpiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 Manufactured by: Boehringer Ingelheim (BI) Pharma GmbH & Co. KG Ingelheim, Germany Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Pfizer, Inc. New York, NY 10017 USA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IICATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IINURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IISYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIBelbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIBelbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIDEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IITOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIMURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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