Recalls / Class II
Class IID-0508-2021
Product
TRI-LO-MARZIA 0.180MG/0.025MG; 0.215 MG/0.025MG AND 0.250MG/0.025MG 3X28 BPK; NDC/UPC 68180-837-73; RX; TABLETS
- Brand name
- Tri-lo-marzia
- Generic name
- Norgestimate And Ethinyl Estradiol
- NDC
- 68180-837
- FDA application
- ANDA200541
- Affected lot / code info
- L001911
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 60 CARTON
- 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-0508-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.