CLASS III Drug recall · Reported 9 Apr 2014 · FDA Enforcement Report
Tivicay (dolutegravir) Tablets 50 mg recalled by Viiv Healthcare
Viiv Healthcare is recalling Tivicay (dolutegravir) Tablets 50 mg, distributed nationwide in the US. The recall was initiated on 11 Feb 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1185-2014
- FDA event ID
- 67606
- Recalling firm
- Viiv Healthcare, Durham, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Feb 2014
- FDA classified
- 1 Apr 2014
- Reported
- 9 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 11 Feb 2014 | Recall initiated by company | |
| 1 Apr 2014 | Classified by FDA | +49 days |
| 9 Apr 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
Product as listed by the FDA
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
Where it was distributed
Nationwide including Puerto Rico
Questions about this recall
Why was it recalled?
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
Which lots are affected?
Lot #: 3ZP2210 Sub-lot A, Expiry: 10/15
Where was it sold?
Nationwide including Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 11 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Tivicay (dolutegravir recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tivicay (dolutegravir) Tablets 50 mg recalled by GlaxoSmithKline | GlaxoSmithKline | Other | Nationwide |