Glycopyrrolate Injection, USP recalled for manufacturing practice deviations
Accord Healthcare recalls Glycopyrrolate Injection USP following FDA inspection identifying manufacturing deviations. Approximately 23,814 vials distributed to the US, Puerto Rico, and Canada are affected.
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: FDA Class II recall for manufacturing practice deviations in a prescription injectable drug product. Manufacturing deviations represent risk-of-harm despite no reported illnesses, meeting the rubric criterion for high-severity recalls.
Plain-English summary
Accord Healthcare, Inc. is recalling Glycopyrrolate Injection, USP 0.2 mg/mL due to manufacturing practice deviations identified during FDA inspection. The affected product consists of single-dose vials distributed to the United States, including Puerto Rico, and Canada.
The recall affects six batches: R2200436, R2200159, R2200166, R2200618, R2201290, and R2201324, with expiration dates ranging from January 2024 to August 2024. Approximately 23,814 vials were distributed.
Healthcare providers with affected inventory should contact Accord Healthcare, Inc. for instruction on how to proceed. This is a Class II recall initiated by the recalling firm.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Prescription Injectable
- 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 (9)
- Batches: R2200436
- Exp. Date 1/31/2024
- R2200159
- R2200166
- R2200618
- Exp. Date 4/30/2024
- R2201290
- Exp. Date 8/31/2024
- R2201324
UPCs (6)
- 0316729474054
- 0316729472302
- 0316729473316
- 0316729471633
- 316729471633
- 316729471084
Distribution
Distribution scope not specified by the agency.
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