February 2021 FDA Recall Metoclopramide by Teva Pharmaceuticals Usa
D-0297-2021 - Chemical contamination; Unknown brown residue adhering to the inside of one vial.

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on February 15, 2021 for the product Metoclopramide. The FDA reported the reason for recall as chemical contamination; unknown brown residue adhering to the inside of one vial.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0297-2021

Reason for Recall
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Initiated
02-15-2021
Reported
03-10-2021
Quantity
9,452 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87330
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, including Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-26-2021
Product Description About Product Description
Full technical description of the product.
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)

Batch or Lot Expiration Information

Lot# 31325335B, exp. date 07/2021

Affected Packages Involved in this Recall

0703-4502-01 Metoclopramide
0703-4502-04 Metoclopramide