Why it was recalled
Failed Dissolution Specifications.
Product description
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61
Lot numbers, UPCs & expiration codes
Lot# T05224; Exp. 02/2026
Where it was sold
Nationwide in the 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-0221-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 30, 2025
- FDA report date
- Feb 12, 2025
- Quantity
- 6997 cartons
- 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-0221-2025, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 96201
- Address
- 341 Mason Rd
- Code information
- Lot# T05224; Exp. 02/2026
- Postal code
- 37086-3606
- Report date
- Feb 12, 2025
- Product type
- Drugs
- Recall number
- D-0221-2025
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Product quantity
- 6997 cartons
- Reason for recall
- Failed Dissolution Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 30, 2025
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2025