Recalls / Class II
Class IID-934-2014
Product
DOCUSATE CALCIUM, Capsule, 240 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375501.
- Affected lot / code info
- DOCUSATE CALCIUM, Capsule, 240 mg has the following codes: Pedigree: AD33897_16, EXP: 5/9/2014; Pedigree: AD49582_16, EXP: 5/16/2014; Pedigree: W002776, EXP: 6/6/2014; Pedigree: W003821, EXP: 6/27/2014.
Why it was recalled
Labeling: Label Mixup: DOCUSATE CALCIUM, Capsule, 240 mg may have potentially been mislabeled as one of the following drugs: diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: AD33897_13, EXP: 5/9/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD49610_1, EXP: 5/16/2014; diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W002775, EXP: 6/6/2014; VITAMIN B
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 1109 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-934-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.