Progesterone Capsules Recalled for Potential Labeling Error
Aidapak Services, LLC is recalling 100 mg progesterone capsules that may have been mislabeled as ascorbic acid tablets.
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 error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling 100 mg progesterone capsules (NDC 00591396401) due to a potential labeling error. The source text indicates that these capsules may have been mislabeled as 250 mg ascorbic acid tablets (NDC 00904052260).
The recalled progesterone capsules have the pedigree AD73611_4 and an expiration date of 5/30/2014. The potentially mislabeled ascorbic acid tablets have the pedigree AD73623_10 and the same expiration date. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for these specific NDC numbers and pedigree codes. If the medication matches the description, they should stop using it and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- PROGESTERONE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591396401.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 99
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)
- PROGESTERONE
- Capsule
- 100 mg has the following codes: Pedigree: AD73611_4
- EXP: 5/30/2014.
Distribution
Part of a larger recall action
This product is one of 265 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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