Why it was recalled
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Product description
Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
Lot numbers, UPCs & expiration codes
Lot: 10292018:21 Exp. 3/31/2019
Where it was sold
WA
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-0343-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 19, 2018
- FDA report date
- Dec 26, 2018
- Quantity
- 85 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharm D Solutions, LLC
Original FDA data
Every field from FDA enforcement report D-0343-2019, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 81629
- Address
- 1304 S Loop W
- Code information
- Lot: 10292018:21 Exp. 3/31/2019
- Postal code
- 77054-4010
- Report date
- Dec 26, 2018
- Product type
- Drugs
- Recall number
- D-0343-2019
- Classification
- Class II
- Recalling firm
- Pharm D Solutions, LLC
- Product quantity
- 85 vials
- Termination date
- Oct 13, 2020
- Reason for recall
- Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
- Distribution pattern
- WA
- Recall initiation date
- Nov 19, 2018
- Initial firm notification
- Telephone
- Center classification date
- Dec 20, 2018