FDAFDA · Food and drugs·Recall number D-0324-2024
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
Published February 21, 2024 · Recall initiated: February 9, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Distributor
- The product was distributed nationwide within the United States.
- Lot
- Lot #: T04680, Exp. Date 6/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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