Aidapak Recalls Methylergonovine Maleate Tablets Due to Labeling Mixup
Aidapak Services, LLC is recalling Methylergonovine Maleate tablets because they may be mislabeled as Isosorbide Mononitrate or Levothyroxine 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling mixup, which is a significant risk but does not involve a structural defect or reported fatalities.
Plain-English summary
Aidapak Services, LLC is recalling Methylergonovine Maleate Tablets, 0.2 mg, NDC 43386014028. The recall was initiated due to a labeling mixup where the product may be mislabeled as Isosorbide Mononitrate, Tablet, 20 mg, or Levothyroxine Sodium, Tablet, 88 mcg.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific codes for the recalled Methylergonovine Maleate tablets are Pedigree AD52778_40 with an expiration date of 5/20/2014, and Pedigree W003477 with an expiration date of 6/20/2014.
Consumers and healthcare providers should check their inventory for these specific NDCs and pedigree codes. If the product is found, it should be returned to the distributor or the recalling firm for credit.
The recalled product
- Product
- METHYLERGONOVINE MALEATE Tablet, 0.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386014028
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 112
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)
- METHYLERGONOVINE MALEATE
- Tablet
- 0.2 mg has the following codes Pedigree: AD52778_40
- EXP: 5/20/2014
- Pedigree: W003477
- EXP: 6/20/2014.
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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