Recalls / Class II
Class IID-0666-2017
Product
ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261
- Affected lot / code info
- a) 129669/C, 129669/F, 129669/H, 129669/J, 130941/B 130941/D, 130941/F, 136108/B, 139091/B; b) 129669/B, 129669/E, 130941/A, 130941/C, 130941/E,130941/G, 136108/A,
Why it was recalled
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Recalling firm
- Firm
- Medisca, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 661 State Route 3 Unit C, N/A, Plattsburgh, New York 12901-6531
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
Timeline
- Recall initiated
- 2017-04-03
- FDA classified
- 2017-04-12
- Posted by FDA
- 2017-04-19
- Terminated
- 2019-06-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0666-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.