Zinc Sulfate Capsules Recalled for Potential Labeling Errors
Aidapak Services is recalling Zinc Sulfate capsules that may be mislabeled as Calcium Acetate or Calcitrol due to a labeling mixup.
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 and involves a labeling mixup, which fits the rubric criterion for minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling Zinc Sulfate Capsules, 220 mg, Over The Counter (NDC 60258-0131-01). The recall is due to a labeling mixup where the product may be potentially mislabeled as Calcium Acetate, Capsule, 667 mg (NDC 00054-0088-26) or Calcitriol, Capsule, 0.25 mcg (NDC 00054-0072-5).
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific codes for the recalled Zinc Sulfate product are Pedigree AD52993_34 with an expiration date of 5/20/2014, and Pedigree W003641 with an expiration date of 6/25/2014.
Consumers should check their medication labels for the NDC 60258-0131-01 and the specific pedigree codes listed above. If the product matches this description, consumers should stop using it and contact their pharmacist or healthcare provider for instructions on disposal or replacement.
The recalled product
- Product
- ZINC SULFATE Capsule, 220 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258013101
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Over-the-Counter
- Hazard
- Affected units
- 200
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)
- ZINC SULFATE
- Capsule
- 220 mg has the following codes Pedigree: AD52993_34
- EXP: 5/20/2014
- Pedigree: W003641
- EXP: 6/25/2014.
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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