7 FDA recalls mention Ethambutol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ethambutol.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Reason CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than…
Reason Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of…
Reason Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Reason Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Reason Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
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