Accord Healthcare Recalls Buspirone Hydrochloride Due to Manufacturing Deviations
Accord Healthcare is recalling 24,408 bottles of Buspirone Hydrochloride tablets due to Current Good Manufacturing Practice deviations discovered during an FDA inspection.
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: This is an FDA Class II recall with no reported illnesses or injuries. The recall is precautionary, based on manufacturing practice deviations discovered during an FDA inspection. Without reported adverse health consequences or identified specific contamination, this qualifies as a precautionary recall.
Plain-English summary
Accord Healthcare, Inc. is recalling Buspirone Hydrochloride Tablets USP, 5 mg, distributed in the United States, Puerto Rico, and Canada. The recall affects two batches: P2200530 (expiring December 31, 2024) and P2105583 (expiring June 30, 2024), with a total of 24,408 bottles recalled.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection. CGMP deviations indicate that the manufacturing, processing, packing, or holding of the product did not meet FDA standards required to ensure product quality, safety, and efficacy.
Buspirone Hydrochloride is a prescription medication used to treat anxiety disorders. Patients currently taking this medication should contact their healthcare provider to discuss available options and determine if they have one of the affected batches.
To check if you have affected product, look at your prescription label for the National Drug Code (NDC) number. The affected packages are NDC 16729-200-01 (100-tablet bottles) and NDC 16729-200-16 (500-tablet bottles). Do not use affected product; contact your pharmacy or healthcare provider.
The recalled product
- Product
- BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
- Brand
- BUSPIRONE HYDROCHLORIDE
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug
- Hazard
- Affected units
- 24,408
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: a) P2200530
- Exp. Date 12/31/2024
- b) P2105583
- Exp. Date 6/30/2024
UPCs (3)
- 0316729289016
- 316729200011
- 316729200165
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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