💊 Drugs Class I - Dangerous
Cross contamination with other products.
All Recalls
95,114 total recalls in our database
💊 Drugs Class I - Dangerous
Cross contamination with other products
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.
Amerisource Health Services
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
CGMP Deviations
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
SYNCHRONICITY SPA INC
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60
Rising Pharma Holding
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
💊 Drugs Class I - Dangerous
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).
Zydus Pharmaceuticals (USA)
💊 Drugs Class I - Dangerous
Cross contamination with other products
💊 Drugs Class I - Dangerous
Subpotent Drug: reduced efficacy for epinephrine
TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
🏥 Medical Devices Class I - Dangerous
We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDMI or MNA-4x0 ENC HDMI. In some instances, this connection may render the first HDMI channel inaccessible, making both the channel and the respective MNA ENC unit unusable. Additionally, readings from the module become unavailable when this issue arises. Similarly, when this Molex module is connected to the ETH0 slot of an MNA-620 ENC ANA, readings may also become inaccessible.
UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
HAND PACK-Procedure Kit Catalog Number: WEHD16B
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
Getinge Usa Sales
🏥 Medical Devices Class I - Dangerous
The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure.
ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.
ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
🏥 Medical Devices Class I - Dangerous
Contact lenses recalled due to potential bacterial contamination.
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.