Why it was recalled
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Product description
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
Lot numbers, UPCs & expiration codes
Lot #: J7N965, Exp. 10/31/2020
Where it was sold
Product was distributed 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-0112-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 15, 2017
- FDA report date
- Dec 27, 2017
- Quantity
- 2,576 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B. Braun Medical Inc
Original FDA data
Every field from FDA enforcement report D-0112-2018, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 78767
- Address
- 2525 McGaw Ave
- Code information
- Lot #: J7N965, Exp. 10/31/2020
- Postal code
- 92614-5841
- Report date
- Dec 27, 2017
- Product type
- Drugs
- Recall number
- D-0112-2018
- Classification
- Class II
- Recalling firm
- B. Braun Medical Inc
- Product quantity
- 2,576 containers
- Termination date
- Oct 18, 2018
- Reason for recall
- Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
- Distribution pattern
- Product was distributed nationwide.
- Recall initiation date
- Dec 15, 2017
- Initial firm notification
- Letter
- Center classification date
- Dec 20, 2017