February 2014 FDA Recall Tivicay by Viiv Healthcare Company
D-1185-2014 - Cross Contamination with Other Products
This Class III drug recall was voluntarily initiated by Viiv Healthcare Company on February 11, 2014 for the product Tivicay. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1185-2014
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
02-11-2014
04-09-2014
1,056 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Viiv Healthcare Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide including Puerto Rico
08-21-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 3ZP2210 Sub-lot A, Expiry: 10/15
