FDA Recalls Ferrous Sulfate Tablets Due to Potential Label Mixup
Aidapak Services is recalling ferrous sulfate tablets that may be mislabeled as ramipril capsules. The error involves a label mixup on repacked drugs.
What this means for you
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 and involves a labeling error (label mixup) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling specific lots of Ferrous Sulfate, Tablet, 325 mg (65 mg Elemental Iron), Over The Counter. The recall is due to a labeling error where the product may be mislabeled as Ramipril, Capsule, 2.5 mg. The affected product has the pedigree AD54553_1 and an expiration date of 5/20/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The mislabeling involves a mixup with Ramipril, Capsule, 2.5 mg, NDC 68180058901, Pedigree AD54549_16, which also has an expiration date of 5/20/2014.
Consumers should check their medication for the specific pedigree and expiration date listed above. If the product matches the recalled description, they should stop using it and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904759160
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Over-the-Counter
- 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)
- FERROUS SULFATE
- Tablet
- 325 mg (65 mg Elemental Iron) has the following code Pedigree: AD54553_1
- EXP: 5/20/2014.
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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