Zinc Sulfate Capsules Recalled for Potential Mislabeling as Sertraline
Aidapak Services is recalling Zinc Sulfate capsules that may be mislabeled as Sertraline HCL tablets. The error could lead to patients taking the wrong medication.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling mixup (mislabeling) without reported injuries or deaths, fitting the Moderate severity criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling Zinc Sulfate, Capsule, 50 mg, Over The Counter, NDC 00904533260. The recall is due to a labeling mixup where the product may be potentially mislabeled as Sertraline HCL, Tablet, 50 mg, NDC 16714061204. The affected Zinc Sulfate capsules have the pedigree AD30994_8 and an expiration date of 5/9/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This labeling error poses a risk because patients or healthcare providers might administer Sertraline HCL instead of Zinc Sulfate, or vice versa, leading to the intake of the wrong medication.
Consumers and healthcare providers should check their inventory for Zinc Sulfate capsules with the specified pedigree and expiration date. If the product is found, it should be stopped and returned to the distributor or recalled firm. Patients should consult their healthcare provider if they have taken the product.
The recalled product
- Product
- ZINC SULFATE, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904533260
- Manufacturer
- Aidapak Services, LLC
- 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)
- ZINC SULFATE
- Capsule
- 50 mg has the following code Pedigree: AD30994_8
- EXP: 5/9/2014.
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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