Why it was recalled
cGMP Deviations; lack of quality assurance.
Product description
ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327
Lot numbers, UPCs & expiration codes
Lots: 052915-1, 052915-2, exp 5/5/2017
Where it was sold
NY, GA, NV, CA, KY, TX
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-0919-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 17, 2017
- FDA report date
- Jun 21, 2017
- Quantity
- 1g=1 bottle; 5g=4 bottle; 25g=3 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Pharmaceutical Ingredients LLC
Original FDA data
Every field from FDA enforcement report D-0919-2017, exactly as published.
Show all FDA fields
- City
- Waterford
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 77465
- Address
- 6650 Highland Rd Ste 302
- Code information
- Lots: 052915-1, 052915-2, exp 5/5/2017
- Postal code
- 48327-1665
- Report date
- Jun 21, 2017
- Product type
- Drugs
- Recall number
- D-0919-2017
- Classification
- Class II
- Recalling firm
- American Pharmaceutical Ingredients LLC
- Product quantity
- 1g=1 bottle; 5g=4 bottle; 25g=3 bottles
- Termination date
- May 31, 2018
- Reason for recall
- cGMP Deviations; lack of quality assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327
- Distribution pattern
- NY, GA, NV, CA, KY, TX
- Recall initiation date
- Apr 17, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 15, 2017