Recalls / Class II
Class IID-935-2014
Product
DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375701.
- Affected lot / code info
- DOCUSATE SODIUM, Capsule, 250 mg has the following codes: Pedigree: AD25452_13, EXP: 5/3/2014; Pedigree: AD54498_4, EXP: 5/20/2014; Pedigree: AD65457_19, EXP: 5/24/2014; Pedigree: W003358, EXP: 6/19/2014; Pedigree: W003558, EXP: 6/24/2014; Pedigree: AD60211_11, EXP: 5/22/2014; Pedigree: W003114, EXP: 6/13/2014; Pedigree: AD37063_4, EXP: 5/13/2014; Pedigree: AD73652_1, EXP: 5/29/2014.
Why it was recalled
Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD25452_10, EXP: 4/30/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD54498_1, EXP: 5/20/2014; LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: AD65457_16, EXP: 5/24/2014; guaiFENesin ER, Table
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 1204 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-935-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.