Recalls / Class II
Class IID-589-2014
Product
DILTIAZEM HCL ER Capsule, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884083109
- Affected lot / code info
- DILTIAZEM HCL ER, Capsule, 240 mg has the following codes Pedigree: AD52375_1, EXP: 5/17/2014; Pedigree: AD56917_1, EXP: 5/21/2014.
Why it was recalled
Labeling: Label Mixup; DILTIAZEM HCL ER Capsule, 240 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD52433_4, EXP: 5/17/2014; PARoxetine HCl, Tablet, 10 mg, NDC 13107015430, Pedigree: AD52778_67, EXP: 5/20/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 180 Capsules
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-589-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.