💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
All Recalls
95,018 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
💊 Drugs Class I - Dangerous
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
💊 Drugs Class I - Dangerous
cGMP deviations
💊 Drugs Class I - Dangerous
cGMP deviations
💊 Drugs Class I - Dangerous
cGMP deviations
💊 Drugs Class I - Dangerous
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
Denver Solutions, LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
Denver Solutions, LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
💊 Drugs Class I - Dangerous
CGMP Deviations
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
Denver Solutions, LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
💊 Drugs Class I - Dangerous
cGMP deviations
💊 Drugs Class I - Dangerous
CGMP Deviations
🏥 Medical Devices Class I - Dangerous
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Merit Medical Systems
🏥 Medical Devices Class I - Dangerous
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Abbott Laboratories
🏥 Medical Devices Class I - Dangerous
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Medtronic MiniMed
🏥 Medical Devices Class I - Dangerous
Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.