Why it was recalled
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Product description
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
Lot numbers, UPCs & expiration codes
Lot Code/Exp. Date: 11061901, 11061803, 11281804, 11291804, 04171902, 05201901, 08121902, EXP 12/31/2020; 08161901, 10111903, EXP 5/31/2021; 11211904, 10161901, EXP 8/31/2021
Where it was sold
Product was distributed to 6 physician's offices within the state of California.
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-0651-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 9, 2019
- FDA report date
- Jan 15, 2020
- Quantity
- 42.12 gm
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Asclemed USA Inc. dba Enovachem Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0651-2020, exactly as published.
Show all FDA fields
- City
- Torrance
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84550
- Address
- 379 Van Ness Ave Ste 1403
- Code information
- Lot Code/Exp. Date: 11061901, 11061803, 11281804, 11291804, 04171902, 05201901, 08121902, EXP 12/31/2020; 08161901, 10111903, EXP 5/31/2021; 11211904, 10161901, EXP 8/31/2021
- Postal code
- 90501-7211
- Report date
- Jan 15, 2020
- Product type
- Drugs
- Recall number
- D-0651-2020
- Classification
- Class II
- Recalling firm
- Asclemed USA Inc. dba Enovachem Pharmaceuticals
- Product quantity
- 42.12 gm
- Termination date
- Aug 9, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
- Distribution pattern
- Product was distributed to 6 physician's offices within the state of California.
- Recall initiation date
- Dec 9, 2019
- Initial firm notification
- Telephone
- Center classification date
- Jan 8, 2020