FDA Recalls Calcium Citrate Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling calcium citrate tablets that may be mislabeled as trimethobenzamide HCL capsules.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as taking the wrong medication) are classified as Severe.
Plain-English summary
Aidapak Services, LLC is recalling 200-tablet bottles of Calcium Citrate, 950 mg (200 mg elemental Ca), tablets. The recall is due to a labeling error where the product may be mislabeled as Trimethobenzamide HCL, 300 mg, capsules.
The affected calcium citrate tablets have the pedigree AD21846_24 and an expiration date of 5/1/2014. The potentially mislabeled trimethobenzamide HCL capsules have the pedigree AD21858_10 and an expiration date of 5/1/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for guidance. The FDA classifies this recall as Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Over-the-Counter
- 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)
- CALCIUM CITRATE
- Tablet
- 950 mg (200 MG ELEMENTAL Ca) has the following code Pedigree: AD21846_24
- EXP: 5/1/2014.
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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