9 FDA recalls mention Amantadine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amantadine.
Reason Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Reason Failed Dissolution Specifications
Reason Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
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 Labeling: Label Mixup: AMANTADINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: MAGNESIUM CHLORIDE…
Reason Labeling: Label Mixup: AMANTADINE HCL, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: ACARBOSE, Tablet, 25 mg…
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