Recalls / Class II
Class IID-565-2014
Product
NIFEDIPINE Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386044024
- Affected lot / code info
- NIFEDIPINE, Capsule, 10 mg has the following codes Pedigree: AD23082_7, EXP: 9/23/2013; Pedigree: AD23082_10, EXP: 9/23/2013.
Why it was recalled
Labeling: Label Mixup; NIFEDIPINE Capsule, 10 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), NDC 64376081501, Pedigree: AD22609_7, EXP: 5/2/2014; NIFEDIPINE, Capsule, 10 mg, NDC 43386044024, Pedigree: AD23082_7, EXP: 9/23/2013.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 202 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-565-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.