Aidapak Recalls Hydrocortisone Tablets Due to Potential Labeling Errors
Aidapak Services, LLC is recalling Hydrocortisone 5 mg tablets that may be mislabeled as Orphenadrine Citrate ER or Calcium Acetate.
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. While mislabeling can lead to medication errors, the source does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Aidapak Services, LLC is recalling Hydrocortisone Tablet, 5 mg, Rx only, NDC 64720033105. The recall is due to a labeling mixup where the product may be potentially mislabeled as Orphenadrine Citrate ER, Tablet, 100 mg, NDC 43386048024, or Calcium Acetate, Capsule, 667 mg, NDC 00054008826.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific codes for the recalled Hydrocortisone tablets are Pedigree W002966 with an expiration date of 6/11/2014, and Pedigree W003046 with an expiration date of 6/12/2014.
Consumers and healthcare providers should check their inventory for these specific NDCs, pedigree numbers, and expiration dates. If the product is found, it should be returned to the distributor or recalled firm for proper disposal or credit.
The recalled product
- Product
- HYDROCORTISONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720033105
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- 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 (5)
- HYDROCORTISONE Tablet
- 5 mg has the following codes Pedigree: W002966
- EXP: 6/11/2014
- Pedigree: W003046
- EXP: 6/12/2014.
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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