Recalls / Class II
Class IID-796-2014
Product
BUPRENORPHINE HCL SL, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054017613.
- Affected lot / code info
- BUPRENORPHINE HCL SL, Tablet, 2 mg has the following codes: Pedigree: AD39573_1, EXP: 5/13/2014; Pedigree: AD54478_1, EXP: 5/20/2014.
Why it was recalled
Labeling: Label Mixup: BUPRENORPHINE HCL SL, Tablet, 2 mg may be potentially mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD37072_4, EXP: 5/13/2014; MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD54510_1, EXP: 2/28/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 60 Tablets
- 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-796-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.