💊 Drugs Class I - Dangerous
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
All Recalls
95,018 total recalls in our database
Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
DuPont Nutrition USA
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
💊 Drugs Class I - Dangerous
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16
Morton Grove Pharmaceuticals
💊 Drugs Class I - Dangerous
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Potential for a wire protrusion through the left heart vent catheter tip
🏥 Medical Devices Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
🏥 Medical Devices Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
🏥 Medical Devices Class I - Dangerous
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
C.R. Bard
🏥 Medical Devices Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
🏥 Medical Devices Class I - Dangerous
Malfunction- loosening of the implant resulting in a potential revision surgery
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
Argon Medical Devices
🏥 Medical Devices Class I - Dangerous
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
Ad-Tech Medical Instrument
🏥 Medical Devices Class I - Dangerous
Incorrect version of labels were used.
Soft Tissue Biopsy Needles
M.D.L. S.r.l.
🏥 Medical Devices Class I - Dangerous
Sterility assurance may be compromised.
Mammary Nodules Localization
M.D.L. S.r.l.
🏥 Medical Devices Class I - Dangerous
Sterility assurance may be compromised.
🏥 Medical Devices Class I - Dangerous
There is a potential for open seals which can compromise sterility.
Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
C.R. Bard
🏥 Medical Devices Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.