Class III · Low risk
Digoxin Tablets
Failed Impurities/Degradation Specifications
Digoxin Tablets
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01
Affected NDC
10135-0747-01
Compare with the code on your package — it is the most precise check available.
Drug: Digoxin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Digoxin NDC 10135-0747 |
.125 mg/1 | Tablet Oral |
Marlex Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Marlex Pharmaceuticals, Inc.
- NDC code
- 10135-0747-01
- Origin
- DE, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Aug 30, 2023 · FDA notice with lot numbers
- FDA recall number
- D-1169-2023 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Digoxin recalls
See all
Class III · Low risk
Digoxin Tablets
Cross Contamination with Other Products:(mycophenolate mofetil).
Class II · Moderate risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class II · Moderate risk
Digoxin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Digoxin
Labeling: Label Mixup: DIGOXIN, Tablet, 125 mcg may have potentially been mislabeled as the following drug: CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: W002581, EXP: 6/3/2014.
Other recalls by Marlex Pharmaceuticals, Inc.
All 2023 recalls
Class II · Moderate risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class II · Moderate risk
Acetaminophen Tablets
CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.
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