Drug 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
D-0666-2017
Product summary
- Firm
- Medisca, Inc.
- Event
- Event 76873
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0666-2017
Official wording
Reason: cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Code information: 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,
Distribution pattern: Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
Derived failure modes
-
Manufacturing or process control
cGMP Deviations