Glycopyrrolate Tablets Recalled Due to Glass Pieces in Sealed Bottles
Aurolife Pharma is recalling Glycopyrrolate Tablets after glass fragments were discovered in a sealed bottle from packaging equipment. Approximately 4,080 bottles were distributed nationwide and in Puerto Rico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Glass contamination in an oral medication represents a risk-of-harm scenario where physical foreign objects could cause injury if ingested. No injuries have been reported to date, but the hazard is real and serious. This meets the rubric criterion for score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Aurolife Pharma, LLC is recalling Glycopyrrolate Tablets, USP 1 mg in 100-count bottles (NDC 13107-014-01) distributed by Aurobindo Pharma USA, Inc. The affected product is from Lot 01421008A1 with an expiration date of March 2023.
Glass fragments were discovered in a sealed bottle. The glass originated from equipment in the manufacturing facility's packaging room. This physical contamination poses a potential risk to consumers who may unknowingly ingest glass pieces.
Approximately 4,080 bottles were distributed nationwide in the USA and Puerto Rico.
Consumers with affected bottles should discontinue use immediately and contact their healthcare provider or pharmacist. The product should be returned to the pharmacy for proper disposal or replacement.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- Aurolife Pharma, LLC
- Category
- Drug — Oral Tablets
- Hazard
- glass-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 01421008A1
- Exp 03/2023
UPCs (1)
- 0313107014017
Distribution
Distributed nationwide across the United States.
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