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.
FDA recall notice · announced June 1, 2016 · Baxter Healthcare
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The 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.
Reason for recall
Presence of Particulate Matter: identified as a cloth fiber.
Notes
Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: P339135, Exp 08/31/2017
Quantity: 334,560 bags
Status: Terminated
Products in this recall event:
- 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553- (D-0862-2016)
- 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553- (D-0861-2016)
- CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 1 (D-0864-2016)
- 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)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.