Par Pharmaceutical Recalls BusPIRone Hydrochloride Tablets Due to Impurity Failure
Par Pharmaceutical Inc. is recalling 11,347 bottles of BusPIRone Hydrochloride Tablets 7.5 mg because they failed impurity and degradation specifications.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating (score 4) under the rubric, as it involves a reasonable probability of temporary or medically reversible adverse health consequences.
Plain-English summary
Par Pharmaceutical Inc. is recalling 11,347 bottles of BusPIRone Hydrochloride Tablets, USP 7.5 mg (NDC# 49884-725-01). The recall is being conducted because the product failed impurity and degradation specifications.
The affected product is identified by Lot # 32091002 with an expiration date of May 2021. The product was distributed to 9 major distributors throughout the United States.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the distributor or the recalling firm for credit.
The recalled product
- Product
- BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
- Manufacturer
- Par Pharmaceutical Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 11,347
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)
- Lot # 32091002
- exp. date May 2021
Distribution
Distribution scope not specified by the agency.
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