Status
Terminated
Drug Enforcement D-776-2014
Labeling: Label Mixup: MONTELUKAST SODIUM, CHEW Tablet, 4 mg may be potentially mislabeled as the following drug: DICYCLOMINE HCL, Tablet, 20 mg, NDC 00591079501, Pedigree: AD76639_4, EXP: 5/31/2014.
Classification
Class II
Report Date
January 29, 2014
Termination Date
February 7, 2014
Product Information
- Product description
- MONTELUKAST SODIUM, CHEW Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006071131.
- Product quantity
- 30 CHEW Tablets
- Reason for recall
- Labeling: Label Mixup: MONTELUKAST SODIUM, CHEW Tablet, 4 mg may be potentially mislabeled as the following drug: DICYCLOMINE HCL, Tablet, 20 mg, NDC 00591079501, Pedigree: AD76639_4, EXP: 5/31/2014.
- 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-776-2014
- Event ID
- 65690
- Recall initiation date
- July 2, 2013
- Center classification date
- January 20, 2014
- Code info
- MONTELUKAST SODIUM, CHEW Tablet, 4 mg has the following codes: Pedigree: AD76639_11, EXP: 5/31/2014.
- More code info
- —