PHENobarbital recall: Labeling Error
PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516832.
Why was PHENobarbital recalled?
Labeling: Label Mixup: PHENobarbital, Tablet, 97.2 mg may have potentially been mislabeled as the following drug: EFAVIRENZ, Capsule, 200 mg, NDC 00056047492, Pedigree: AD46312_31, EXP: 5/16/2014.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
PHENobarbital, Tablet, 97.2 mg has the following codes: Pedigree: AD46339_1, EXP: 5/16/2014.
- Product
- PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516832.
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 1000 Tablets
- Distribution
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Recall date
- January 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)