FDA Recalls Accord Healthcare Buspirone 15 mg Tablets for Manufacturing Deviations
Accord Healthcare is recalling 10,992 bottles of Buspirone Hydrochloride 15 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing quality control deviations found 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 recall is classified as FDA Class II, which indicates potential for adverse health consequences in pharmaceutical manufacturing. CGMP deviations can affect product quality and safety. No illnesses or injuries have been reported in the source material, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Accord Healthcare, Inc. is recalling Buspirone Hydrochloride Tablets USP 15 mg. The recall was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations.
The recalled product is manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India, and distributed in 100-count bottles. Approximately 10,992 bottles were distributed throughout the United States, including Puerto Rico and Canada. The affected batch is P2105483 with an expiration date of July 31, 2024, and bears NDC 16729-203-01.
The FDA has classified this recall as a Class II recall.
The recalled product
- Product
- BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
- Brand
- BUSPIRONE HYDROCHLORIDE
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Prescription Oral Tablets
- 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 (2)
- Batches: P2105483
- Exp. Date 7/31/2024
UPCs (2)
- 0316729289016
- 316729203012
Distribution
Distribution scope not specified by the agency.
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