Why it was recalled
Failed impurities/ degradation specifications: Out of specification for organic impurities.
Product description
Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
Lot numbers, UPCs & expiration codes
Lot #:17010401181119190927, EXP 12/2020, 1701040118111919092725200122, EXP.12/2020
Where it was sold
U.S.A. Nationwide
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-1284-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 15, 2020
- FDA report date
- Jun 10, 2020
- Quantity
- 210 grams
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- TRIOVA PHARMACEUTICALS LLC
Original FDA data
Every field from FDA enforcement report D-1284-2020, exactly as published.
Show all FDA fields
- City
- Tulsa
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 85704
- Address
- 115 W 3rd St Ste 720
- Code information
- Lot #:17010401181119190927, EXP 12/2020, 1701040118111919092725200122, EXP.12/2020
- Postal code
- 74103-3410
- Report date
- Jun 10, 2020
- Product type
- Drugs
- Recall number
- D-1284-2020
- Classification
- Class II
- Recalling firm
- TRIOVA PHARMACEUTICALS LLC
- Product quantity
- 210 grams
- Termination date
- Jun 1, 2023
- Reason for recall
- Failed impurities/ degradation specifications: Out of specification for organic impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- May 15, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 1, 2020