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Serious recall: Injury is possible or has been reported. Take action promptly.

Accord Healthcare, Inc. 2023-03-08 Health serious FDA
Health · FDA · Recall #FDA-D-0378-2023

BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for:… Recall

Issued March 8, 2023 · Accord Healthcare, Inc.

In March 2023, Accord Healthcare, Inc. recalled the BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for:…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

CGMP Deviations: recalling drug products following an FDA inspection.

What you should do

  1. 1 Stop using BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for:… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Accord Healthcare, Inc. to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Accord Healthcare, Inc.
Category
Health
Recall date
March 8, 2023
Units affected
Not reported
Sold at
United States including Puerto Rico and Canada
Recall number
FDA-D-0378-2023
Made in
United States
Issuing agency
FDA

In context

  • Accord Healthcare, Inc. has 31 recalls in our database, including 1 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 903rd Health recall we've logged in 2023.
Read the official FDA notice

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