Aidapak Recalls Trazodone Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Trazodone HCl 150 mg tablets because they may be mislabeled as Nicotine Polacrilex or Sennosides.
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, which corresponds to a Severe severity score under the rubric, particularly given the risk of patients receiving the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling Trazodone HCl Tablet, 150 mg, NDC 50111044101, due to a labeling error. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recalled Trazodone tablets may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, or SENNOSIDES, Tablet, 8.6 mg. The specific pedigree codes and expiration dates for the potentially mislabeled products are AD21858_1 (EXP: 5/1/2014) and W003256 (EXP: 6/17/2014), respectively. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for the NDC 50111044101 and the specific pedigree codes listed in the recall notice. If the medication is mislabeled, patients should contact their healthcare provider or pharmacist for guidance on appropriate alternatives.
The recalled product
- Product
- traZODone HCl Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111044101
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 300
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)
- traZODone HCl
- Tablet
- 150 mg has the following codes Pedigree: AD21858_7
- EXP: 5/1/2014
- Pedigree: W003245
- EXP: 6/17/2014.
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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