The Recall Desk
SevereFDA (Drugs)·D-494-2014·Announced 2014-01-22

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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

Distributed in 4 states:

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.

See all 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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