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
Reported: April 8, 2020 Initiated: March 30, 2020 #D-1071-2020
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.
Details
- Recalling Firm
- Par Pharmaceutical Inc.
- Units Affected
- 29,352 bottles
- Distribution
- Product was distributed within the United States.
- Location
- Chestnut Ridge, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Par Pharmaceutical Inc.. Units affected: 29,352 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 8, 2020. Severity: Moderate. Recall number: D-1071-2020.
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