Recalls / Class II
Class IID-936-2014
Product
DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375710.
- Affected lot / code info
- DOCUSATE SODIUM, Capsule, 250 mg has the following codes: Pedigree: W003054, EXP: 6/12/2014; Pedigree: AD21846_11, EXP: 5/1/2014; Pedigree: W002512, EXP: 6/3/2014; Pedigree: AD76675_1, EXP: 6/3/2014; Pedigree: W002694, EXP: 6/5/2014; Pedigree: AD46257_16, EXP: 5/15/2014; Pedigree: AD60236_1, EXP: 5/22/2014; Pedigree: AD60578_5, EXP: 5/29/2014; Pedigree: AD73521_13, EXP: 5/30/2014; Pedigree: W003242, EXP: 6/17/2014; Pedigree: W003315, EXP: 6/18/2014.
Why it was recalled
Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: W003030, EXP: 6/12/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: AD21790_64, EXP: 5/1/2014; TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg), NDC 00591533501, Pedigree: AD7
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 16,044 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-936-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.