Why it was recalled
Lack of Assurance of Sterility: Potential leakage of bags.
Product description
fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL. Volume: 150 mL. Single dose cassette For: Methodist Dallas Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-278-86
Lot numbers, UPCs & expiration codes
Lot #: 5/14/18 1012 172-27886Y, BUD 6/28/2018.
Where it was sold
Nationwide in the USA
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-0946-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 12, 2018
- FDA report date
- Jul 25, 2018
- Quantity
- 100 cassettes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
Original FDA data
Every field from FDA enforcement report D-0946-2018, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 80307
- Address
- 24416 N 19th Ave
- Code information
- Lot #: 5/14/18 1012 172-27886Y, BUD 6/28/2018.
- Postal code
- 85085-1887
- Report date
- Jul 25, 2018
- Product type
- Drugs
- Recall number
- D-0946-2018
- Classification
- Class II
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
- Product quantity
- 100 cassettes
- Termination date
- Jan 24, 2020
- Reason for recall
- Lack of Assurance of Sterility: Potential leakage of bags.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL. Volume: 150 mL. Single dose cassette For: Methodist Dallas Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-278-86
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 12, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 19, 2018