Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
All Recalls
95,018 total recalls in our database
GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19
Novel Laboratories, Inc. d.b.a LUPIN
💊 Drugs Class I - Dangerous
Failed Stability Specification; Out of specification for Osmolarity
Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10
Spirit Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP deviations: Discolored acetaminophen
Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
DuPont Nutrition USA
💊 Drugs Class I - Dangerous
Out of specification results for conductivity.
Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
Zydus Pharmaceuticals (USA)
💊 Drugs Class I - Dangerous
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4
High Performance Formulas, L.L.C. (HPF, L.L.C.)
💊 Drugs Class I - Dangerous
Marketed Without an Approved NDA/ANDA
🏥 Medical Devices Class I - Dangerous
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
🏥 Medical Devices Class I - Dangerous
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Trilogy Evo Universal, Product number DS2000X11B
Philips Respironics
🏥 Medical Devices Class I - Dangerous
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
🏥 Medical Devices Class I - Dangerous
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Potential for leaks and loosening at the patient catheter connection
🏥 Medical Devices Class I - Dangerous
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.