Class III · Low risk Terminated
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East…
Reason Failed Impurities/Degradation Specifications
DIGOXIN, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115981101.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup: DIGOXIN, Tablet, 0.125 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD21846_34, EXP: 5/1/2014; DESMOPRESSIN ACETATE, Tablet, 0.1 mg, NDC 00591246401, Pedigree: AD46426_16, EXP: 5/15/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 00603548221, Pedigree: AD60264_1, EXP: 5/22/2014; LIOTHYRONINE SODIUM,
What was recalled
DIGOXIN, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115981101.
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-861-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Digoxin recalls
See all
Class III · Low risk Terminated
Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East…
Reason Cross Contamination with Other Products:(mycophenolate mofetil).
Class II · Moderate risk Terminated
Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New…
Reason 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…
Class I · High risk Terminated
Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New…
Reason 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…
Class II · Moderate risk Terminated
Digoxin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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