FDA Recalls Calcium Citrate Tablets Due to Potential Label Mixup
Aidapak Services is recalling Calcium Citrate tablets that may be mislabeled as Tizanidine HCl. The error could lead to patients taking the wrong medication.
What this means for you
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, which typically involves a labeling error that could result in temporary or medically reversible health consequences. The hazard is a label mixup between two different drugs, which is a significant but correctable error.
Plain-English summary
Aidapak Services, LLC is recalling 298-tablet bottles of Calcium Citrate, Tablet, 950 mg (200 mg Elem Calcium), NDC 00904506260. The recall is due to a labeling error where the product may be mislabeled as Tizanidine HCl, Tablet, 2 mg, NDC 57664050289. The affected product has the pedigree W003720 and an expiration date of 6/26/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This labeling mixup poses a risk because Tizanidine is a muscle relaxer, while Calcium Citrate is a dietary supplement. Patients or consumers relying on the label could inadvertently take the wrong medication.
Consumers should check their medication labels for the NDC 00904506260 or the pedigree W003720. If the product is found, it should be returned to the pharmacy or point of purchase. Patients currently taking the medication should consult their healthcare provider if they have questions about the recall.
The recalled product
- Product
- CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Calcium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Over-the-Counter
- Hazard
- Affected units
- 298
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)
- CALCIUM CITRATE
- Tablet
- 950 mg (200 mg Elem Calcium) has the following code Pedigree: W003720
- EXP: 6/26/2014.
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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