Lanthanum Carbonate Chew Tablets Recalled for Potential Label Mixup
Aidapak Services is recalling Lanthanum Carbonate Chew Tablets due to a potential label mixup with other medications. The repacked drugs were distributed in four western states.
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), as they may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Aidapak Services, LLC is recalling Lanthanum Carbonate Chew Tablets, 500 mg, NDC 54092025290, due to a potential label mixup. The recall involves 405 chew tablets that may be mislabeled as Isoniazid, Cyanocobalamin, or Magnesium Chloride tablets. The affected products have expiration dates ranging from May 13, 2014, to June 19, 2014, and specific pedigree codes are listed in the recall notice.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected Lanthanum Carbonate Chew Tablets and contact their pharmacist or the recalling firm for instructions on how to return the product. Patients should verify the medication label and NDC number against the recall details to ensure they are not using the mislabeled product.
The recalled product
- Product
- LANTHANUM CARBONATE Chew Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092025290
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 405
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 (10)
- LANTHANUM CARBONATE
- Chew Tablet
- 500 mg has the following codes Pedigree: AD32764_5
- EXP: 5/13/2014
- Pedigree: AD32764_8
- EXP: 5/14/2014
- Pedigree: W002790
- EXP: 6/6/2014
- Pedigree: W003410
- EXP: 6/19/2014.
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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