Recalls / Class II
Class IID-612-2014
Product
TRIMETHOBENZAMIDE HCl Capsule, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 53489037601
- Affected lot / code info
- TRIMETHOBENZAMIDE HCl, Capsule, 300 mg has the following codes Pedigree: AD21858_10, EXP: 5/1/2014; Pedigree: AD70625_1, EXP: 5/29/2014; Pedigree: W002976, EXP: 6/11/2014.
Why it was recalled
Labeling: Label Mixup; TRIMETHOBENZAMIDE HCl, Capsule, 300 mg may be potentially mislabeled as GABAPENTIN, Tablet, 600 mg, NDC 00228263611, Pedigree: AD21965_7, EXP: 5/1/2014; CHOLECALCIFEROL, Capsule, 5000 units, NDC 00904598660, Pedigree: AD70629_19, EXP: 5/29/2014; SODIUM BICARBONATE, Tablet, 650 mg, NDC 64980018210, Pedigree: W002970, EXP: 6/11/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 300 Capsules
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-612-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.