FDA (Drugs) recall action 97777
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
The agency’s own wording, quoted from the enforcement report.
The Harvard Drug Group is recalling Gabapentin Capsules USP 100 mg in 10-capsule blister packs after routine stability testing returned an out-of-specification result for highest unknown impurity.
The Harvard Drug Group is recalling Gabapentin Capsules USP 100 mg across several lots after routine stability testing returned an out-of-specification result for highest unknown impurity.