Recalls / Class II
Class IID-0524-2021
Product
Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA
- Brand name
- Steglatro
- Generic name
- Ertugliflozin
- Active ingredient
- Ertugliflozin Pidolate
- Route
- Oral
- NDCs
- 0006-5363, 0006-5364
- FDA application
- NDA209803
- Affected lot / code info
- T013566
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Merck Sharp & Dohme LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 215 bottles
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0524-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.