💊 Drugs Class I - Dangerous
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
All Recalls
95,038 total recalls in our database
Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
Asclemed USA Inc.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
AAA Pharmaceutical
💊 Drugs Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
AAA Pharmaceutical
💊 Drugs Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
💊 Drugs Class I - Dangerous
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
💊 Drugs Class I - Dangerous
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
💊 Drugs Class I - Dangerous
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
💊 Drugs Class I - Dangerous
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
Asclemed USA Inc.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
Asclemed USA Inc.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
🏥 Medical Devices Class I - Dangerous
Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or partially blocked. This may cause the closed suction catheters (CSCs) to inadequately suction secretions and/or saline fluids form the patient's airway to prevent oxygen desaturation.
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Implant Direct Sybron Manufacturing
🏥 Medical Devices Class I - Dangerous
The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Implant Direct Sybron Manufacturing
🏥 Medical Devices Class I - Dangerous
The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.
Intersurgical
🏥 Medical Devices Class I - Dangerous
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.
Intersurgical
🏥 Medical Devices Class I - Dangerous
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
Nextremity Solutions
🏥 Medical Devices Class I - Dangerous
Components 2mm shorter than indicated on the package label
🏥 Medical Devices Class I - Dangerous
Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal.
Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.
Intersurgical
🏥 Medical Devices Class I - Dangerous
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.