Aidapak Recalls Calcium Carbonate Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling 10,819 tablets of Calcium Carbonate +D3 because they may be mislabeled as Digoxin or Amantadine 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 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, and the hazard involves potential mislabeling of a calcium supplement as Digoxin or Amantadine HCl, which are potent prescription medications with significant safety risks if taken incorrectly.
Plain-English summary
Aidapak Services, LLC is recalling 10,819 tablets of Calcium Carbonate +D3, 600 mg/400 units, due to a potential label mixup. The recalled product, distributed by AidaPak Service, LLC, may be mislabeled as Digoxin, 125 mcg tablets, or Amantadine HCl, 100 mg tablets. This labeling error could result in patients receiving the wrong medication.
The recalled tablets are identified by the following codes: Pedigree W002610 with an expiration date of 6/4/2014, and Pedigree AD54576_1 with an expiration date of 5/20/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for these specific lot codes and expiration dates. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have taken the product and are concerned about potential mislabeling.
The recalled product
- Product
- CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904323392.
- Manufacturer
- Aidapak Services, LLC
- Affected units
- 10,819
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 (6)
- CALCIUM CARBONATE +D3
- Tablet
- 600 mg/400 units has the following codes: Pedigree: W002610
- EXP: 6/4/2014
- Pedigree: AD54576_1
- EXP: 5/20/2014.
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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