Marlex Pharmaceuticals, Inc.

FDA Regulatory Profile

Marlex Pharmaceuticals, Inc. appears in FDA public data with 3 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 8 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1170-2023, Class II) was initiated on August 25, 2023.

Summary

Total Recalls
3 (1 Class I)
510(k) Clearances
0
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1170-2023Class IIDigoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex PhAugust 25, 2023
D-1169-2023Class IDigoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex PAugust 25, 2023
D-1064-2013Class IIAcetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New August 8, 2013