Recalls / Class II
Class IID-1071-2020
Product
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
- Affected lot / code info
- Lot # 32809101, Exp 3/2021
Why it was recalled
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Recalling firm
- Firm
- Par Pharmaceutical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Ram Ridge Rd, N/A, Chestnut Ridge, New York 10977-6714
Distribution
- Quantity
- 29,352 bottles
- Distribution pattern
- Product was distributed within the United States.
Timeline
- Recall initiated
- 2020-03-30
- FDA classified
- 2020-03-30
- Posted by FDA
- 2020-04-08
- Terminated
- 2021-11-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1071-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.