Status
Terminated
Drug Enforcement D-665-2014
Labeling:Label Mixup; QUEtiapine FUMARATE Tablet, 100 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: W002776, EXP: 6/6/2014; NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: W003823, EXP: 6/27/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60578_5, EXP: 5/29/2014.
Classification
Class II
Report Date
January 22, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- QUEtiapine FUMARATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505313301
- Product quantity
- 1,300 Tablets
- Reason for recall
- Labeling:Label Mixup; QUEtiapine FUMARATE Tablet, 100 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: W002776, EXP: 6/6/2014; NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: W003823, EXP: 6/27/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60578_5, EXP: 5/29/2014.
- 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-665-2014
- Event ID
- 65707
- Recall initiation date
- July 2, 2013
- Center classification date
- January 16, 2014
- Code info
- QUEtiapine FUMARATE, Tablet, 100 mg has the following codes Pedigree: W002777, EXP: 6/6/2014; Pedigree: W003825, EXP: 6/27/2014; Pedigree: AD73623_13, EXP: 5/30/2014.
- More code info
- —