Recalls / Class II
Class IID-0622-2020
Product
Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA
- Affected lot / code info
- Lot #156110 A-P Lot #153328 A-D Lot #161726 A-L
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Medisca, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 661 State Route 3 Unit C, Plattsburgh, New York 12901-6531
Distribution
- Quantity
- 640,325 grams
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-11-25
- FDA classified
- 2019-12-16
- Posted by FDA
- 2019-12-25
- Terminated
- 2021-03-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0622-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.