💊 Drugs Class I - Dangerous
Superpotent; Hydrochlorothiazide
All Recalls
95,018 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Valgene Incorporated
💊 Drugs Class I - Dangerous
Lack of Processing Controls
💊 Drugs Class I - Dangerous
Superpotent Drug
💊 Drugs Class I - Dangerous
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Valgene Incorporated
💊 Drugs Class I - Dangerous
Lack of Processing Controls
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
Preferred Pharmaceuticals
💊 Drugs Class I - Dangerous
Defective container: Out of specification for container integrity leading to bottles leaking.
EVLP Convenience Pack/Kit
Medline Industries
🏥 Medical Devices Class I - Dangerous
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.
Venous Access Pack-LF Convenience Kit
Medline Industries
🏥 Medical Devices Class I - Dangerous
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Cardinal Health
🏥 Medical Devices Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
🏥 Medical Devices Class I - Dangerous
Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.
🏥 Medical Devices Class I - Dangerous
Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Cardinal Health
🏥 Medical Devices Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
🏥 Medical Devices Class I - Dangerous
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
🏥 Medical Devices Class I - Dangerous
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Cardinal Health
🏥 Medical Devices Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
🏥 Medical Devices Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns