Par recalls 100-count Phenoxybenzamine Hydrochloride Capsules (10mg) due to failed impurities and degradation specifications. This prescription drug may pose risks if used as intended.
Failed Impurities/Degradation Specifications
Par is recalling prescription Phenoxybenzamine Hydrochloride Capsules (10mg) because they failed impurities and degradation tests. This could lead to unsafe drug levels if used as intended.
The capsules failed impurities and degradation specifications, meaning they may contain unsafe levels of impurities or break down into harmful substances. This could lead to unexpected side effects or reduced effectiveness of the drug.
Prescription drug users who have the specific 100-count bottles with NDC 49884-038-01 and lot number 15429401. Patients taking this medication for hypertension or other conditions are most at risk.
Check for the 100-count bottles labeled 'Phenoxybenzamine Hydrochloride Capsules, USP 10mg' with NDC 49884-038-01 and lot number 15429401. The product was distributed by Par Pharmaceutical Chestnut Ridge, NY.
Look for the NDC code 49884-038-01 and lot number 15429401 on the bottle.
The recall states the product failed impurities and degradation specifications, so it may not be safe. Consult your doctor if you have this product.
The recall record does not mention a remedy or replacement process.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Par to request your refund or repair — edit it as you like.
Subject: Recall D-0061-2023 — Par Par Hello, I own a Par that is covered by recall D-0061-2023 from Par. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
