Recalls / Class II
Class IID-0221-2025
Product
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
- Brand name
- Potassium Chloride
- Generic name
- Potassium Chloride
- Active ingredient
- Potassium Chloride
- Route
- Oral
- NDC
- 0904-7216
- FDA application
- ANDA210921
- Affected lot / code info
- Lot# T05224; Exp. 02/2026
Why it was recalled
Failed Dissolution Specifications.
Recalling firm
- Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- 6997 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-01-30
- FDA classified
- 2025-02-04
- Posted by FDA
- 2025-02-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0221-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.