Recalls / Class III
Class IIID-1185-2014
Product
Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13
- Brand name
- Tivicay
- Generic name
- Dolutegravir Sodium
- Active ingredient
- Dolutegravir Sodium
- Route
- Oral
- NDCs
- 49702-226, 49702-255, 49702-227, 49702-228
- FDA application
- NDA204790
- Affected lot / code info
- Lot #: 3ZP2210 Sub-lot A, Expiry: 10/15
Why it was recalled
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
Recalling firm
- Firm
- Viiv Healthcare Company
- Manufacturer
- ViiV Healthcare Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5 Moore Dr, N/A, Durham, North Carolina 27709-0143
Distribution
- Quantity
- 1,056 bottles
- Distribution pattern
- Nationwide including Puerto Rico
Timeline
- Recall initiated
- 2014-02-11
- FDA classified
- 2014-04-01
- Posted by FDA
- 2014-04-09
- Terminated
- 2014-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1185-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.