Aidapak Recalls Niacin TR Tablets Due to Potential Labeling Error
Aidapak Services, LLC is recalling Niacin TR 750 mg tablets because they may have been mislabeled as Nortriptyline HCL 50 mg capsules.
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. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential mislabeling that could lead to incorrect medication administration.
Plain-English summary
Aidapak Services, LLC is recalling Niacin TR, Tablet, 750 mg (NDC 00536703301) due to a labeling error. The source text indicates that the Niacin TR tablets may have potentially been mislabeled as Nortriptyline HCL, Capsule, 50 mg (NDC 00093081201). Both products share the same expiration date of May 16, 2014, and the Niacin TR tablets are identified by pedigree AD46414_56.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as FDA Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should check their inventory for Niacin TR, Tablet, 750 mg with pedigree AD46414_56 and expiration date 5/16/2014. If found, these products should be quarantined and returned to the distributor or manufacturer for credit. Patients should consult their healthcare provider if they have taken the medication and experience any adverse effects.
The recalled product
- Product
- NIACIN TR, Tablet, 750 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00536703301.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 100
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)
- NIACIN TR
- Tablet
- 750 mg has the following codes: Pedigree: AD46414_56
- EXP: 5/16/2014.
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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