BusPIRone Hydrochloride Tablets recall: Impurity Out of Spec
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Why was BusPIRone Hydrochloride Tablets recalled?
Failed Impurity /Degradation Specifications
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 32091002, exp. date May 2021
- Product
- BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
- Recalling firm
- Par Pharmaceutical Inc.
- Quantity
- 11,347 bottles
- Distribution
- Product was distributed to 9 major distributors throughout the United States.
- Recall date
- September 2, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)