Calcium Citrate Tablets Recalled for Potential Lithium Carbonate Labeling Error
Aidapak Services is recalling Calcium Citrate tablets that may be mislabeled as Lithium Carbonate ER. The error could lead to incorrect medication administration.
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, which corresponds to a Severe severity score under the rubric. The hazard involves a significant labeling error that could result in the administration of the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling Calcium Citrate tablets, 950 mg (200 mg elemental calcium), 200-count bottles. The recall is due to a labeling error where the product may be mislabeled as Lithium Carbonate ER, 450 mg tablets.
The affected product is identified by NDC 00904506260, pedigree AD46257_43, and expiration date 5/15/2014. The mislabeled product may bear the NDC 00054002025, pedigree AD46265_10, and expiration date 5/15/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication labels for the specific NDC and pedigree codes listed above. If the product matches the description, they should stop using it and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), 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 Calcium) has the following code Pedigree: AD46257_43
- EXP: 5/15/2014.
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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