Class III · Low risk Terminated
Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536…
Reason FAILED CONTENT UNIFORMITY SPECIFICATIONS
3 FDA recalls mention Risedronate. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Risedronate.
Reason FAILED CONTENT UNIFORMITY SPECIFICATIONS
Reason Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Reason Failed Dissolution Specifications
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