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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

American Health Packaging Hydralazine Hydrochloride Tablets Recalled for Impurities

Agency Publication Date: October 5, 2023
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Summary

Amerisource Health Services LLC is recalling 3,344 cartons of American Health Packaging Hydralazine Hydrochloride (hydralazine hydrochloride) 10 mg tablets, a medication used to treat high blood pressure. The recall was issued because the tablets failed impurity and degradation specifications during a 12-month testing point. No incidents or injuries have been reported to date.

Risk

The product exceeded specification limits for impurities, which may affect the medication's quality and long-term stability. While no injuries are reported, consuming medication with excessive degradation products could potentially lead to health risks.

What You Should Do

  1. This recall affects American Health Packaging Hydralazine Hydrochloride Tablets, USP, 10 mg, packaged in 100-tablet cartons (10 x 10 blister packs) with lot number 1007002 and an expiration date of 12/31/2023.
  2. If you have health concerns regarding this medication, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amerisource Health Services LLC for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: HydrALAZINE Hydrochloride Tablets, USP, 10 mg (100 Tablets)by American Health Packaging
Variants: 10 mg, Tablet
Lot Numbers:
1007002 (Exp 12/31/2023)
NDC:
68084-447-01
68084-447-11

Recall #: D-0039-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93089
Status: Resolved
Manufacturer: Amerisource Health Services LLC
Sold By: American Health Packaging
Manufactured In: United States
Units Affected: 3,344 cartons
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.