Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.
Reported: April 6, 2022 Initiated: March 17, 2022 #D-0736-2022
Product Description
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.
Reason for Recall
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Details
- Recalling Firm
- Aurolife Pharma, LLC
- Units Affected
- 4080 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-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.. Recalled by Aurolife Pharma, LLC. Units affected: 4080 bottles.
Why was this product recalled? ▼
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 6, 2022. Severity: Moderate. Recall number: D-0736-2022.
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