Aidapak Recalls Digoxin Tablets Due to Potential Label Mixup
Aidapak Services is recalling Digoxin 125 mcg tablets because they may have been mislabeled as Cholecalciferol/Calcium/Phosphorus tablets.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe).
Plain-English summary
Aidapak Services, LLC is recalling Digoxin, Tablet, 125 mcg, NDC 00527132401. The recall was initiated because the product may have been mislabeled as Cholecalciferol/Calcium/Phosphorus, Tablet, 120 units/105 mg/81 mg, NDC 64980015001.
The affected Digoxin tablets have the pedigree AD76675_4 and an expiration date of 6/3/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers who have this product should contact their pharmacist or healthcare provider for instructions on how to proceed. The FDA has classified this recall as Class II.
The recalled product
- Product
- DIGOXIN, Tablet, 125 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527132401.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- DIGOXIN
- Tablet
- 125 mcg has the following codes: Pedigree: AD76675_4
- EXP: 6/3/2014.
Distribution
Part of a larger recall action
This product is one of 265 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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