Drug product
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.
D-0863-2016
Product summary
- Event
- Event 73118
- Status
- Terminated
- Classification
- Class I
- Quantity
- 334,560 bags
- Official record key
drug-enforcement:D-0863-2016
Official wording
Reason: Presence of Particulate Matter: identified as a cloth fiber.
Code information: Lot #: P339135, Exp 08/31/2017
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter