Amerisource Health Services GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton recall — FDA D-0520-2017
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Overview of recall records associated with Amerisource Health Services, including dates, categories and classifications where available.
Classification mix: Class II: 12, Class III: 5.
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
This page summarizes recall records in which the official source identifies Amerisource Health Services as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.