Recalls / Class II
Class IID-0736-2022
Product
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.
- Brand name
- Glycopyrrolate
- Generic name
- Glycopyrrolate
- Active ingredient
- Glycopyrrolate
- Route
- Oral
- NDCs
- 13107-014, 13107-015
- FDA application
- ANDA202675
- Affected lot / code info
- Lot: 01421008A1, Exp 03/2023
Why it was recalled
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Recalling firm
- Firm
- Aurolife Pharma, LLC
- Manufacturer
- Aurolife Pharma LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 US Highway 130, N/A, Dayton, New Jersey 08810-1519
Distribution
- Quantity
- 4080 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2022-03-17
- FDA classified
- 2022-03-30
- Posted by FDA
- 2022-04-06
- Terminated
- 2024-03-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0736-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.