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D-0863-2016 Class I Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA drug recall D-0863-2016 was initiated by Baxter Healthcare Corp. on Jan 21, 2016 and is designated Class I. Reason for recall: Presence of Particulate Matter: identified as a cloth fiber. The recall status is terminated (terminated Feb 26, 2018). Affected quantity: 334,560 bags.

Recall Details

Product Type: Drugs
Report Date: Jun 1, 2016
Initiation Date: Jan 21, 2016
Termination Date: Feb 26, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 334,560 bags

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.

Reason for Recall

Presence of Particulate Matter: identified as a cloth fiber.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: P339135, Exp 08/31/2017

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