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All product recalls associated with ACCELERA.
Total Recalls
8
Past Year
1
Class I (Serious)
0
Most Recent
Jun 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
PT. Elangperdana Tyre Industry (EP Tyre) is recalling certain Accelera Omikron A/T tires, size LT265/65R18A. The sidewall may separate near the tire bead. As such, these tires fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 139, "New Pneumatic Radial Tires for Light Vehicles."
CGMP deviations
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.
The product was mislabeled as Vegan Product but contains anchovies
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).