Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10

FDA recall notice · announced April 24, 2024 · Novitium Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10

Reason for recall

Failed Impurities/Degradation Specifications

Notes

Distribution: U.S. Nationwide
Lot/code information: Lot M23011A; Exp. 12/2024
Quantity: 1,003 bottles
Status: Terminated
Products in this recall event:
- Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10 (D-0443-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.