D-1071-2020 Class II Terminated
FDA drug recall D-1071-2020 was initiated by Par Pharmaceutical Inc. on March 30, 2020 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specification: Presence of unknown impurity observed. The recall status is terminated (terminated November 2, 2021). Affected quantity: 29,352 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 8, 2020
- Initiation Date
- March 30, 2020
- Termination Date
- November 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,352 bottles
Product Description
Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01
Reason for Recall
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Distribution Pattern
Product was distributed within the United States.
Code Information
Lot # 32809101, Exp 3/2021