Accord Healthcare Recalls Buspirone Hydrochloride Tablets Due to Manufacturing Violations
Accord Healthcare is recalling Buspirone Hydrochloride tablets due to manufacturing process deviations found during an FDA inspection. The recall affects approximately 3,784 bottles distributed in the United States, Puerto Rico, and Canada.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: FDA Class II recall with no reported illnesses, injuries, or deaths and no specific identified contamination. The hazard is a manufacturing process deviation (CGMP violation), which constitutes a precautionary action.
Plain-English summary
Accord Healthcare, Inc. is recalling Buspirone Hydrochloride Tablets USP, 10 mg, manufactured by Intas Pharmaceuticals Limited. The recall covers approximately 3,784 bottles from batch P2105472 with an expiration date of April 30, 2024.
The recall was issued following an FDA inspection that identified deviations from Current Good Manufacturing Practice (CGMP) requirements. The company is taking this precautionary action to ensure product quality and safety.
The affected products were distributed in the United States, including Puerto Rico, and Canada. Patients currently taking Buspirone Hydrochloride from the recalled batch should consult their healthcare provider or pharmacist about obtaining a replacement product.
Consumers who have this product should stop using it and contact their pharmacy or healthcare provider for guidance. Additional information about the recall is available from Accord Healthcare, Inc.
The recalled product
- Product
- BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
- Brand
- BUSPIRONE HYDROCHLORIDE
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,784
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: P2105472
- Exp. Date 4/30/2024
UPCs (2)
- 0316729289016
- 316729202169
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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