FDA recalls Buspirone Hydrochloride tablets for manufacturing practice deviations
Accord Healthcare is recalling approximately 25,812 bottles of Buspirone Hydrochloride 30mg tablets due to manufacturing practice deviations discovered during an FDA inspection.
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: This FDA Class II recall is driven by manufacturing practice deviations without documented illnesses or injuries. Per the rubric, this represents a High (3) severity rating as it is a risk-of-harm scenario without reported injury.
Plain-English summary
Accord Healthcare, Inc. is recalling Buspirone Hydrochloride Tablets USP 30 mg in 60-count bottles (NDC 16729-289-12, batch P2105551, expiration July 31, 2024) due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection.
Approximately 25,812 bottles have been affected. The recalled product was distributed throughout the United States, including Puerto Rico and Canada.
Consumers in possession of the recalled medication should contact their healthcare provider or pharmacist for guidance. Do not stop taking the medication or discard it without consulting a healthcare provider.
The recalled product
- Product
- BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
- Brand
- BUSPIRONE HYDROCHLORIDE
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Antianxiety
- Hazard
- Affected units
- 25,812
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)
- Batches: P2105551
- Exp. Date 7/31/2024
UPCs (2)
- 0316729289016
- 316729289122
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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