FDAFDA · Food and drugs·Recall number D-1071-2020
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
Published April 8, 2020 · Recall initiated: March 30, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Par Pharmaceutical Inc.
- Distributor
- Product was distributed within the United States.
- Lot
- Lot # 32809101, Exp 3/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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