Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle recall — FDA D-0104-2019
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Complete FDA and NHTSA recall records dated in 2018, organized for browsing by month, category and recalling company.
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Records are ordered by the best available source date.
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Cross Contamination With Other Products:
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Chrysler (FCA US LLC) is recalling certain 2018-2019 Jeep Wrangler vehicles. The front track bar brackets may be improperly welded, which can cause the bracket to separate from the frame,…
Honda (American Honda Motor Co.) is recalling certain 2019 Honda Insight, Odyssey, and Ridgeline vehicles. The Supplemental Restraint System (SRS) control unit may have a manufacturing…
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr…
There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could…
Products are labeled with an incorrect expiration date
The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of…
The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of…
The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for…
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.