Recall Enforment Report D-0695-2021
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by API Solutions Inc., originally initiated on 07-15-2021 for the 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 The product was recalled due to cgmp deviations. The product was distributed in Al, Az, Co, Fl, Va and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0695-2021 | 07-15-2021 | 08-04-2021 | Class II | 20 bottles | 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 | cGMP Deviations | Terminated |
| D-0696-2021 | 07-15-2021 | 08-04-2021 | Class II | 1 bottle | Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York | cGMP Deviations | Terminated |
