Aidapak Recalls Cholecalciferol Tablets Due to Potential Labeling Errors
Aidapak Services, LLC is recalling Cholecalciferol/Calcium/Phosphorus tablets because they may be mislabeled as Promethazine HCl or Valsartan.
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 are assigned a score of 4 (Severe), particularly given the risk of patients receiving incorrect medications.
Plain-English summary
Aidapak Services, LLC is recalling 509 tablets of Cholecalciferol/Calcium/Phosphorus (120 units/105 mg/81 mg), NDC 64980015001. The recall is due to a labeling error where the product may be mislabeled as Promethazine HCl (25 mg) or Valsartan (40 mg).
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific lots involved include Pedigree W002581 (Expiration 6/3/2014) and Pedigree AD32345_1 (Expiration 5/14/2014).
Consumers should check their medication for these specific NDC and pedigree codes. If the product matches the description, they should stop using it and contact their pharmacist or the recalling firm for instructions.
The recalled product
- Product
- CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS Tablet, 120 units/105 mg/81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980015001
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Tablets
- Hazard
- Affected units
- 509
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 (5)
- CHOLECALCIFEROL/CALCIUM/PHOSPHORUS Tablet
- 120 units/105 mg/81 mg has the following codes Pedigree: W002581
- EXP: 6/3/2014
- Pedigree: AD32345_1
- EXP: 5/14/2014.
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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