Recall: D-1082-2023

Class III - Minor Violations

Class IIIClassification

2023-07-18Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

Product

Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86

Reason

Out of Specification result observed in content uniformity testing

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.