Glycopyrrolate injection recalled due to manufacturing practice deviations
Accord Healthcare recalls Glycopyrrolate injection due to manufacturing practice deviations found during FDA inspection. The recall affects 3,164 vials distributed in the US, Puerto Rico, and Canada.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for manufacturing practice deviations identified during inspection. No illnesses, injuries, or deaths have been reported. The hazard is based on process deviations rather than an identified defect, making this a precautionary recall.
Plain-English summary
Glycopyrrolate injection (1 mg/5 mL, 0.2 mg/mL) manufactured by Accord Healthcare, Inc. is being recalled due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The recall affects 3,164 vials distributed across four affected batches with expiration dates ranging from February 2024 to August 2024.
The recalled product was distributed throughout the United States, including Puerto Rico and Canada. Healthcare facilities and distributors are advised to identify and quarantine affected inventory from batches R2200259, R2200258, R2200617, and R2201308.
Healthcare providers and patients with this medication should contact their supplier or healthcare provider for guidance on next steps. No illnesses or injuries related to this product have been reported.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Injection
- Hazard
- manufacturing-deviation
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 (7)
- Batches: R2200259
- Exp. Date 2/29/2024
- R2200258
- R2200617
- Exp. Date 4/30/2024
- R2201308
- Exp. Date 8/31/2024
UPCs (6)
- 0316729474054
- 0316729472302
- 0316729473316
- 0316729471633
- 316729473316
- 316729473033
Distribution
Distribution scope not specified by the agency.
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