Recalls / Class II
Class IID-926-2014
Product
ACETAMINOPHEN, CHEW Tablet, 80 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536323307.
- Affected lot / code info
- ACETAMINOPHEN, CHEW Tablet, 80 mg has the following codes: Pedigree: AD49399_1, EXP: 5/16/2014; Pedigree: W003113, EXP: 6/13/2014; Pedigree: AD30180_7, EXP: 5/8/2014; Pedigree: W003050, EXP: 6/12/2014.
Why it was recalled
Labeling: Label Mixup: ACETAMINOPHEN, CHEW Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: AD49423_1, EXP: 5/16/2014; ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003101, EXP: 6/13/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD30028_1, EXP: 5/8/2014; TACROLIMUS,
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 120 CHEW 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-926-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.