Why it was recalled
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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: T04680, Exp. Date 6/2024
Where it was sold
The product was distributed nationwide within the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0324-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 9, 2024
- FDA report date
- Feb 21, 2024
- Quantity
- 8,198 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Original FDA data
Every field from FDA enforcement report D-0324-2024, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 93929
- Address
- 341 Mason Rd
- Code information
- Lot #: T04680, Exp. Date 6/2024
- Postal code
- 37086-3606
- Report date
- Feb 21, 2024
- Product type
- Drugs
- Recall number
- D-0324-2024
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Product quantity
- 8,198 units
- Termination date
- Dec 22, 2025
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- The product was distributed nationwide within the United States.
- Recall initiation date
- Feb 9, 2024
- Initial firm notification
- Center classification date
- Feb 13, 2024