HydrALAZINE Hydrochloride Tablets recalled due to impurity specifications failure
Amerisource Health Services LLC is recalling HydrALAZINE Hydrochloride Tablets, 10 mg, nationwide due to impurities exceeding specifications in a repackaged product batch.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall (lowest agency classification) with no reported illnesses or injuries. The hazard is theoretical—impurities exceeding specifications in a repackaged product were identified through quality testing, not through patient harm reports.
Plain-English summary
Amerisource Health Services LLC is recalling HydrALAZINE Hydrochloride Tablets, USP, 10 mg, distributed nationwide. The recall affects 3,344 cartons with lot number 1007002, expiration date 12/31/2023, distributed under carton NDC 68084-447-01 and individual dose NDC 68084-447-11.
The recall was initiated because the repackaged product failed impurities and degradation specifications, with out-of-specification results detected during quality testing at the 12-month time point. This indicates that impurity levels exceeded acceptable standards for the medication.
Patients taking this medication should contact their pharmacist or healthcare provider to confirm whether their medication is from the recalled lot. Do not discontinue use without consulting your healthcare provider. Your pharmacist can verify your medication's lot number and provide a replacement if necessary.
The recalled product
- Product
- HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Hazard
- impurity
- degradation-failure
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#: 1007002
- Exp 12/31/2023
Distribution
Distributed nationwide across the United States.
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