Recalls / Class II
Class IID-905-2014
Product
TEMAZEPAM, Capsule, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378311001.
- Affected lot / code info
- TEMAZEPAM, Capsule, 7.5 mg has the following codes: Pedigree: AD22861_7, EXP: 5/8/2014; Pedigree: AD49418_1, EXP: 5/17/2014.
Why it was recalled
Labeling: Label Mixup: TEMAZEPAM, Capsule, 7.5 mg may have potentially been mislabeled as one of the following drugs: CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium, NDC 00904506260, Pedigree: AD28333_1, EXP: 5/8/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD49414_7, EXP: 5/17/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 200 Capsules
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-905-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.