Aidapak Recalls Niacin TR Capsules Due to Potential Label Mixup
Aidapak Services is recalling Niacin TR capsules because they may have been mislabeled as other drugs like Perphenazine or Melatonin.
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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant harm (such as taking the wrong medication) are rated as Severe.
Plain-English summary
Aidapak Services, LLC is recalling Niacin TR, Capsule, 500 mg, NDC 00904063160. The recall is due to a labeling error where the product may have been mislabeled as other medications, including Perphenazine, Melatonin, Cranberry Extract/Vitamin C, or Glucosamine.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall covers specific lots with expiration dates ranging from May 15, 2014, to June 18, 2014. The agency classifies this as a Class II recall.
Consumers should check their medication labels and contact their pharmacist or healthcare provider if they have the affected product. Do not take the medication if the label does not match the prescription.
The recalled product
- Product
- NIACIN TR, Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904063160.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 504
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 (12)
- NIACIN TR
- Capsule
- 500 mg has the following codes: Pedigree: AD46257_22
- EXP: 5/15/2014
- Pedigree: AD60240_17
- EXP: 5/22/2014
- Pedigree: W002696
- EXP: 6/5/2014
- Pedigree: AD73521_22
- EXP: 5/30/2014
- Pedigree: W003318
- EXP: 6/18/2014.
Distribution
Part of a larger recall action
This product is one of 265 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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