Sildenafil Citrate Tablets Recalled for Potential Labeling Error
Aidapak Services, LLC is recalling Sildenafil Citrate 25 mg tablets that may have been mislabeled as a different 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 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 Sildenafil Citrate, Tablet, 25 mg (NDC 00069420030) due to a potential labeling error. The recalled product may have been mislabeled as PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg (NDC 66213042510). The affected product has the pedigree W003646 and an expiration date of 6/25/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for Sildenafil Citrate 25 mg tablets with the specified pedigree and expiration date. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- SILDENAFIL CITRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069420030.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 30
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)
- SILDENAFIL CITRATE
- Tablet
- 25 mg has the following codes: Pedigree: W003646
- EXP: 6/25/2014.
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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