The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0377-2023·Announced 2023-03-08

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.

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 3/5 (High).

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
Affected units
10,992

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

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.

See all 67 products in this recall →

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