Reason: Lack of assurance of sterility.
Distributed: Distributed Nationwide in th USA, Puerto Rico and US Virgin IslandsReason: Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
Distributed: Nationwide in the U.S.Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Distributed: FLReason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Distributed: FLReason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Distributed: FLReason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distributed: Within the U.S in FL and CA.Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distributed: Within the U.S in FL and CA.Reason: Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
Distributed: CAReason: Defective Delivery System: customer complaints exceeded respective action limits.
Distributed: Nationwide to the U.S. MarketReason: CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Distributed: Nationwide to the U.S. market