Why it was recalled
Lack of Assurance of Sterility
Product description
Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, Houston, Texas
Lot numbers, UPCs & expiration codes
Lot: a) 04132018:97 Discard by: 10/10/2018; 04032018:25 Discard by: 9/30/2018; b) 04162018:29 Discard by: 10/11/2018; 03282018:80 Discard by: 9/24/2018; 06122018:06 Discard by: 12/9/2018; 08132018:55 Discard by: 2/9/2019
Where it was sold
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-0190-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 10, 2018
- FDA report date
- Nov 7, 2018
- Quantity
- 553 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharm D Solutions, LLC
Original FDA data
Every field from FDA enforcement report D-0190-2019, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 81002
- Address
- 1304 S Loop W
- Code information
- Lot: a) 04132018:97 Discard by: 10/10/2018; 04032018:25 Discard by: 9/30/2018; b) 04162018:29 Discard by: 10/11/2018; 03282018:80 Discard by: 9/24/2018; 06122018:06 Discard by: 12/9/2018; 08132018:55 Discard by: 2/9/2019
- Postal code
- 77054-4010
- Report date
- Nov 7, 2018
- Product type
- Drugs
- Recall number
- D-0190-2019
- Classification
- Class II
- Recalling firm
- Pharm D Solutions, LLC
- Product quantity
- 553 vials
- Termination date
- Feb 5, 2021
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Powder NDC 69699-1353-10, Pharm D Solutions, Houston, Texas
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 10, 2018
- Initial firm notification
- Press Release
- Center classification date
- Nov 1, 2018