Magnesium Gluconate Tablets Recalled for Potential Label Mixup
Aidapak Services is recalling Magnesium Gluconate Dihydrate tablets because they may be mislabeled as hydrALAZINE HCl.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling mixup, which fits the rubric for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling Magnesium Gluconate Dihydrate Tablets, 500 mg (27 mg Elemental Magnesium), Over The Counter, NDC 60258017201. The recall is due to a labeling mixup where the product may be potentially mislabeled as hydrALAZINE HCl, Tablet, 100 mg, NDC 23155000401.
The affected product is identified by the pedigree AD30197_16 and an expiration date of 5/9/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for the specific NDC and pedigree listed above. If the product matches the description, they should stop using it and contact their pharmacist or the recalling firm for instructions.
The recalled product
- Product
- MAGNESIUM GLUCONATE DIHYDRATE Tablet, 500 mg (27 mg Elemental Magnesium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258017201
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Over-The-Counter
- Hazard
- Affected units
- 100
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 (3)
- MAGNESIUM GLUCONATE DIHYDRATE
- Tablet
- EXP: 5/9/2014.
Distribution
Part of a larger recall action
This product is one of 273 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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