FDA Recalls Melatonin Tablets Due to Potential Labeling Errors
Aidapak Services, LLC is recalling 1 mg melatonin tablets that may be mislabeled as quetiapine fumarate or docusate sodium.
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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly given the risk of mislabeling a sleep aid as a psychiatric medication.
Plain-English summary
Aidapak Services, LLC is recalling 1 mg melatonin tablets (NDC 04746900466) due to a labeling error. The recall involves 359 tablets that may be potentially mislabeled as Quetiapine Fumarate 12.5 mg tablets (NDC 47335090288) or Docusate Sodium 250 mg capsules (NDC 00536375710).
The affected melatonin tablets have pedigree codes AD21846_17 with an expiration date of 5/1/2014, or AD73521_19 with an expiration date of 5/30/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for these specific NDC numbers and pedigree codes. If the product matches the description, they should stop using it and contact their pharmacist or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- MELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 04746900466
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Over-The-Counter
- Hazard
- Affected units
- 359
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)
- MELATONIN
- Tablet
- 1 mg has the following codes Pedigree: AD21846_17
- EXP: 5/1/2014
- Pedigree: AD73521_19
- EXP: 5/30/2014.
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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