FDA recall record

Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials recall — FDA D-0297-2021

Chemical contamination; Unknown brown residue adhering to the inside of one vial.

Class IIclassification
D-0297-2021official record ID
Mar 10, 2021report date

Recall record at a glance

Official recordD-0297-2021
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmTeva Pharmaceuticals USA
Report dateMar 10, 2021
Recall initiation dateFeb 15, 2021
Quantity9,452 cartons
LocationParsippany, NJ, United States

Official product description

Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray)

Why the product was recalled

Chemical contamination; Unknown brown residue adhering to the inside of one vial.

Distribution information

Nationwide, including Puerto Rico

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.

Related recall records

Other records from the same recalling company are shown first when available.