Recall Register

Drug recall: Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva…

Class II FDA enforcement event 87330. Recall start date: . Status in the FDA record: Terminated. Termination date: .

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

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

Teva Pharmaceuticals USA started this drug recall on 15 Feb 2021. The firm address in the FDA record is in Parsippany, NJ. FDA put the recall in Class II. FDA event 87330 has 1 product record. The first FDA enforcement report date is 10 Mar 2021. The record gives the status Terminated, with the termination date 26 Aug 2021.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

Nationwide, including Puerto Rico

Recalling firm

Teva Pharmaceuticals USA, Parsippany, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 87330: product records
Recall numberProductQuantityClassStatusReport date
D-0297-2021Metoclopramide 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)9,452 cartonsClass IITerminated10 Mar 2021

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2021
299
Share of these events in Class II
60%
Product records in this event
1Median of the firm: 1
Events of the firm on the register
98

Other events of the firm

Other FDA enforcement events of Teva Pharmaceuticals USA
InitiatedProduct (first record)TypeClassRecords
18 Jan 2022Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, ManufaDrugClass II1
10 Jan 2022Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-08DrugClass II1
7 Jan 2022Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, ManufDrugClass III2
31 Dec 2021MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, ManufactuDrugClass II2
16 Dec 2021Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDrugClass II1
8 Dec 2021Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropperDrugClass II1
28 Oct 2021Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT IDrugClass III1
27 Oct 2021Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) ManufacDrugClass II1
22 Sep 2021AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, RDrugClass II5
29 Jul 2021Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis LaboratoriDrugClass II3

Teva Pharmaceuticals USA: all 98 events

Official channels

Cite this page

Recall Register. FDA enforcement event 87330. https://recallregister.com/fda/ii/87330/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA drug enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Nationwide, including Puerto Rico
What quantity of product is in FDA event 87330?
The FDA record gives this quantity: 9,452 cartons
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2021 have the same class?
60% of the 299 drug events that started in 2021 are in Class II.