Status
Terminated
Drug Enforcement D-820-2014
Labeling: Label Mixup: carBAMazepine ER, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: ISOSORBIDE DINITRATE ER, Tablet, 40 mg, NDC 57664060088, Pedigree: AD23082_4, EXP: 5/3/2014; SIROLIMUS, Tablet, 1 mg, NDC 00008104105, Pedigree: W003329, EXP: 6/18/2014.
Classification
Class II
Report Date
January 29, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- carBAMazepine ER, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078051005.
- Product quantity
- 200 Tablets
- Reason for recall
- Labeling: Label Mixup: carBAMazepine ER, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: ISOSORBIDE DINITRATE ER, Tablet, 40 mg, NDC 57664060088, Pedigree: AD23082_4, EXP: 5/3/2014; SIROLIMUS, Tablet, 1 mg, NDC 00008104105, Pedigree: W003329, EXP: 6/18/2014.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location & Firm
- Recalling firm
- Aidapak Services, LLC
- Address
-
14301 Se 1st St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-820-2014
- Event ID
- 65690
- Recall initiation date
- July 2, 2013
- Center classification date
- January 20, 2014
- Code info
- carBAMazepine ER, Tablet, 100 mg has the following codes: Pedigree: AD30140_22, EXP: 5/7/2014; Pedigree:W003330, EXP: 6/18/2014.
- More code info
- —