Par Pharmaceutical Glycopyrrolate Tablets, USP 1 mg, 100-count bottle recall — FDA D-1071-2020
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Overview of recall records associated with Par Pharmaceutical, Inc., including dates, categories and classifications where available.
Classification mix: Class III: 6, Class II: 2.
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Subpotent Drug; Ethinyl Estradiol
Subpotent Drug; Ethinyl Estradiol
Subpotent Drug; Ethinyl Estradiol
Subpotent Drug; Ethinyl Estradiol
Subpotent Drug; Ethinyl Estradiol
This page summarizes recall records in which the official source identifies Par Pharmaceutical, Inc. 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.