Status
Terminated
Drug Enforcement D-802-2014
Labeling: Label Mixup: PHENOL, LOZENGE, 29 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 00378201777, Pedigree: AD49582_10, EXP: 5/16/2014; VITAMIN B COMPLEX W/C, Tablet, 0 mg, NDC 00904026013, Pedigree: AD60240_48, EXP: 5/22/2014.
Classification
Class II
Report Date
January 29, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- PHENOL, LOZENGE, 29 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00068021918.
- Product quantity
- 180 Lozenges
- Reason for recall
- Labeling: Label Mixup: PHENOL, LOZENGE, 29 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 20 mg, NDC 00378201777, Pedigree: AD49582_10, EXP: 5/16/2014; VITAMIN B COMPLEX W/C, Tablet, 0 mg, NDC 00904026013, Pedigree: AD60240_48, EXP: 5/22/2014.
- 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-802-2014
- Event ID
- 65690
- Recall initiation date
- July 2, 2013
- Center classification date
- January 20, 2014
- Code info
- PHENOL, LOZENGE, 29 mg has the following codes: Pedigree: AD49582_13, EXP: 5/16/2014; Pedigree: AD60428_4, EXP: 5/22/2014.
- More code info
- —