Why it was recalled
cGMP Deviations
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: ETL181001, Exp 10/09/2021
Where it was sold
AL, AZ, CO, FL, VA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0695-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 15, 2021
- FDA report date
- Aug 4, 2021
- Quantity
- 20 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- API Solutions Inc.
Original FDA data
Every field from FDA enforcement report D-0695-2021, exactly as published.
Show all FDA fields
- City
- Daphne
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 88289
- Address
- 25309 Friendship Rd
- Code information
- Lot #: ETL181001, Exp 10/09/2021
- Postal code
- 36526-6278
- Report date
- Aug 4, 2021
- Product type
- Drugs
- Recall number
- D-0695-2021
- Classification
- Class II
- Recalling firm
- API Solutions Inc.
- Product quantity
- 20 bottles
- Termination date
- Feb 8, 2022
- Reason for recall
- cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- AL, AZ, CO, FL, VA
- Recall initiation date
- Jul 15, 2021
- Initial firm notification
- Letter
- Center classification date
- Jul 28, 2021