Why it was recalled
Lack of sterility assurance.
Product description
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
Lot numbers, UPCs & expiration codes
Lot #: 138-20190205@3, Exp . Date 10/29/2019; 138-20190705@7, Exp. Date 11/3/2019
Where it was sold
Nationwide within the United States
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-0152-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 18, 2019
- FDA report date
- Oct 30, 2019
- Quantity
- 808 droptainers
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
Original FDA data
Every field from FDA enforcement report D-0152-2020, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 83833
- Address
- 24416 N 19th Ave
- Code information
- Lot #: 138-20190205@3, Exp . Date 10/29/2019; 138-20190705@7, Exp. Date 11/3/2019
- Postal code
- 85085-1887
- Report date
- Oct 30, 2019
- Product type
- Drugs
- Recall number
- D-0152-2020
- Classification
- Class II
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
- Product quantity
- 808 droptainers
- Termination date
- Dec 4, 2019
- Reason for recall
- Lack of sterility assurance.
- Product description
- Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Sep 18, 2019
- Center classification date
- Oct 18, 2019