CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Reason for recall: CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. Distribution: Nationwide within the United States Quantity: 27,868 blister packs Lot/code info: Lot #: 1017392, Exp. Date 01/31/2026; 1017415, Exp. Date 12/31/2025.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.