Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Where is Dolutegravir made?
2 companies sell it under their own name and 4 repackagers rebottle it. None of their labels names the factory.
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Mylan Laboratories Limited10 mg · NDC 65015-353 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ViiV Healthcare Company Tivicay, Tivicay PD5 mg, 10 mg, 25 mg, 50 mg · NDC 49702-226, 49702-227, 49702-255 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Dolutegravir in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- RPK Pharmaceuticals, Inc.:
53002-1810 - RedPharm Drug. Inc.:
67296-1818 - St. Mary's Medical Park Pharmacy:
60760-748 - State of Florida DOH Central Pharmacy:
53808-1130
Recalls
- May 17, 2024 · Class III · GlaxoSmithKline LLC
Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR. - May 13, 2022 · Class III · GlaxoSmithKline LLC
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026. - Feb 11, 2014 · Class III · Viiv Healthcare Company
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.