Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Reason for recall: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. Distribution: Nationwide within the USA Quantity: 5,703 bottles Lot/code info: Lot #: 31013A, Exp. Date 11/2025; 40345A, 40355A, Exp. Date 4/2026; 40571A, 40580A, Exp. Date 6/2026; 40587A, 40591A, Exp. Date 7/2026; 40870.1, 40877.1, Exp. Date 10/2026; 41093A, Exp. Date 12/2026; 50072A, 50079A, Exp. Date 1/2027
Official record: FDA (Drug enforcement) ↗
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