Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Reported: December 28, 2022 Initiated: December 16, 2022 #D-0087-2023
Product Description
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Reason for Recall
Failed Impurities/Degradation Specifications
Details
- Recalling Firm
- Aurolife Pharma, LLC
- Units Affected
- 7344 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- Dayton, NJ
Frequently Asked Questions
What product was recalled? ▼
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01. Recalled by Aurolife Pharma, LLC. Units affected: 7344 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 28, 2022. Severity: Moderate. Recall number: D-0087-2023.
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