Why it was recalled
Presence of Particulate Matter: identified as a cloth fiber.
Product description
Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.
Lot numbers, UPCs & expiration codes
Lot #: P339135, Exp 08/31/2017
Where it was sold
Nationwide and Puerto Rico
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-0863-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 21, 2016
- FDA report date
- Jun 1, 2016
- Quantity
- 334,560 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-0863-2016, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 73118
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: P339135, Exp 08/31/2017
- Postal code
- 60015-4625
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0863-2016
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 334,560 bags
- Termination date
- Feb 26, 2018
- Reason for recall
- Presence of Particulate Matter: identified as a cloth fiber.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jan 21, 2016
- Initial firm notification
- Letter
- Center classification date
- May 23, 2016