Status
Terminated
Drug Enforcement D-1006-2014
Labeling: Label Mixup: TACROLIMUS, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003168, EXP: 6/13/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: W003350, EXP: 6/18/2014.
Classification
Class II
Report Date
January 29, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- TACROLIMUS, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210201.
- Product quantity
- 200 Capsules
- Reason for recall
- Labeling: Label Mixup: TACROLIMUS, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003168, EXP: 6/13/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: W003350, 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-1006-2014
- Event ID
- 65690
- Recall initiation date
- July 2, 2013
- Center classification date
- January 20, 2014
- Code info
- TACROLIMUS, Capsule, 0.5 mg has the following codes: Pedigree: W003169, EXP: 6/13/2014; Pedigree: W003351, EXP: 6/18/2014.
- More code info
- —