Buspirone Hydrochloride tablets recalled for manufacturing practice deviations
Accord Healthcare is recalling Buspirone Hydrochloride 7.5 mg tablets (23,784 bottles) distributed in the US, Puerto Rico, and Canada due to manufacturing practice deviations identified during FDA inspection.
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 recall is classified as FDA Class II with no reported illnesses or injuries and manufacturing practice deviations identified during inspection. Per the severity rubric, precautionary recalls with theoretical hazards and no adverse events are rated Moderate (2).
Plain-English summary
Accord Healthcare, Inc. is recalling certain Buspirone Hydrochloride Tablets USP 7.5 mg that were distributed in the United States, including Puerto Rico and Canada. The product was manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India, and packaged in 100-count bottles.
The recall affects approximately 23,784 bottles with the following batch numbers and expiration dates: Batch P2105532 (expiration 6/30/2024) and Batch P2200348 (expiration 12/31/2024).
The recall was initiated following an FDA inspection that identified deviations from Current Good Manufacturing Practice (CGMP) standards. No illnesses or injuries associated with this product have been reported.
The recalled product
- Product
- BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
- Brand
- BUSPIRONE HYDROCHLORIDE
- Manufacturer
- Accord Healthcare, Inc.
- Hazard
- manufacturing-defect
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 (4)
- Batches: P2105532
- Exp. Date 6/30/2024
- P2200348
- Exp. Date 12/31/2024
UPCs (1)
- 0316729289016
Distribution
Distribution scope not specified by the agency.
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