Status
Terminated
Drug Enforcement D-585-2014
Labeling: Label Mixup; ASPIRIN EC DR Tablet, 81 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD28322_7, EXP: 5/6/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: W003671, EXP: 6/25/2014.
Classification
Class II
Report Date
January 22, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- ASPIRIN EC DR Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348098015
- Product quantity
- 544 Tablets
- Reason for recall
- Labeling: Label Mixup; ASPIRIN EC DR Tablet, 81 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD28322_7, EXP: 5/6/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: W003671, EXP: 6/25/2014.
- 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-585-2014
- Event ID
- 65707
- Recall initiation date
- July 2, 2013
- Center classification date
- January 16, 2014
- Code info
- ASPIRIN EC DR, Tablet, 81 mg has the following codes Pedigree: AD28349_1, EXP: 2/28/2014; Pedigree: W003672, EXP: 2/28/2014.
- More code info
- —