Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Product description
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
Lot numbers, UPCs & expiration codes
Lot #: T03755, T03756, Exp. Date 03/2023
Where it was sold
Nationwide within USA
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-0653-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 24, 2022
- FDA report date
- Mar 23, 2022
- Quantity
- 5,953 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group
Original FDA data
Every field from FDA enforcement report D-0653-2022, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 89663
- Address
- 17187 N Laurel Park Dr Ste 300
- Code information
- Lot #: T03755, T03756, Exp. Date 03/2023
- Postal code
- 48152-2600
- Report date
- Mar 23, 2022
- Product type
- Drugs
- Recall number
- D-0653-2022
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group
- Product quantity
- 5,953 cartons
- Termination date
- Jul 16, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
- Distribution pattern
- Nationwide within USA
- Recall initiation date
- Feb 24, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 14, 2022