Why it was recalled
Lack of assurance of sterility
Product description
Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Lot numbers, UPCs & expiration codes
Lot# 138-20180409@55, Exp 11/18/2018
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-0135-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 19, 2018
- FDA report date
- Nov 7, 2018
- Quantity
- 300 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
Original FDA data
Every field from FDA enforcement report D-0135-2019, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 81413
- Address
- 24416 N 19th Ave
- Code information
- Lot# 138-20180409@55, Exp 11/18/2018
- Postal code
- 85085-1887
- Report date
- Nov 7, 2018
- Product type
- Drugs
- Recall number
- D-0135-2019
- Classification
- Class II
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
- Product quantity
- 300 bags
- Termination date
- May 6, 2021
- Reason for recall
- Lack of assurance of sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
- Distribution pattern
- U.S.A. nationwide.
- Recall initiation date
- Oct 19, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 1, 2018