Class I
Terminated
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.
This recall has been terminated (originally issued June 1, 2016).
- Company
- Baxter Healthcare Corp.
- Recall Initiated
- January 21, 2016
- Posted
- June 1, 2016
- Recall Number
- D-0863-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 334,560 bags
- Firm Location
- Deerfield, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Particulate Matter: identified as a cloth fiber.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: P339135, Exp 08/31/2017
More recalls by Baxter Healthcare Corp.
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634
Product Usage:...
Nov 8, 2016
V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -...
Sep 28, 2016
Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Co...
Sep 28, 2016
Other recent Class I Drug recalls
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactu...
Mckesson
· Feb 18, 2026
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLu...
Green Lumber Holdings, Llc
· Feb 11, 2026
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India...
Handelnine Global Llc
· Feb 11, 2026
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNat...
Medinatura New Mexico, Inc.
· Jan 14, 2026
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, L...
Fresenius Kabi Usa, Llc
· Dec 3, 2025