Recalls / Class II
Class IID-1140-2015
Product
Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11
- Affected lot / code info
- Lot #140849
Why it was recalled
Failed dissolution specifications
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 925 cartons (30 tablets in each carton)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-03-02
- FDA classified
- 2015-06-16
- Posted by FDA
- 2015-06-24
- Terminated
- 2015-10-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1140-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.