Phenoxybenzamine Hydrochloride Capsules Recalled for Failed Specifications
Par Pharmaceutical is recalling Phenoxybenzamine Hydrochloride Capsules 10mg nationwide due to failed impurity and degradation specifications. The recalled lot may not meet pharmaceutical quality standards.
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: FDA Class II recall for a pharmaceutical with quality failures (impurities and degradation) that present a risk of harm through compromised drug efficacy or safety. No illnesses or injuries have been reported, meeting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Par Pharmaceutical is recalling one lot of Phenoxybenzamine Hydrochloride Capsules, USP 10mg, distributed nationwide in 100-count bottles. The affected lot (15429401, expiration date August 2023) comprises approximately 21,800 capsules that failed to meet impurity and degradation specifications required for pharmaceutical quality and safety.
Phenoxybenzamine is an alpha-adrenergic blocking agent used to manage hypertension in patients with pheochromocytoma and other conditions. When medications fail impurity or degradation specifications, they may not deliver intended therapeutic effects or could contain breakdown products that compromise drug quality. No illnesses or adverse events related to this lot have been reported.
Consumers with bottles bearing lot number 15429401 (expiration 08/2023) should consult their healthcare provider or pharmacist immediately. Do not discontinue the medication without medical guidance. Return the recalled product to the dispensing pharmacy for proper disposal or request a replacement from another manufacturer.
The recalled product
- Product
- Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01
- Manufacturer
- Par Formulations Private Limited
- Hazard
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 #: 15429401
- Exp. Date 08/2023
Distribution
Distributed nationwide across the United States.
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