Drug product
Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01
D-0695-2021
Product summary
- Event
- Event 88289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 bottles
- Official record key
drug-enforcement:D-0695-2021
Official wording
Reason: cGMP Deviations
Code information: Lot #: ETL181001, Exp 10/09/2021
Distribution pattern: AL, AZ, CO, FL, VA
Derived failure modes
-
Manufacturing or process control
cGMP Deviations