Drug recalls

Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054.…

Teva Pharmaceuticals USA, Inc · Presence of Foreign Tablets/Capsules

Class IIOngoingD-0038-2027
Status
Ongoing
City
Parsippany
State
NJ
Country
United States
Classification
Class II
Product type
Drugs
Event ID
100013
Recalling firm
Teva Pharmaceuticals USA, Inc
Address 1
400 Interpace Pkwy Bldg A
Postal code
07054-1120
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Distribution pattern
US Nationwide.
Recall number
D-0038-2027
Product quantity
240,448 cartons
Reason for recall
Presence of Foreign Tablets/Capsules
Recall initiation date
20260929
Center classification date
20261013
Report date
20261021
Code info
Lot, expiry: [100 Tablets] Lots 8634085, 8635085, 8636085, exp 07/2027; [500 Tablets] Lot 8633085, exp 07/2027
Product description

Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05

Harmonized identifiers (openFDA)
Application number
ANDA070184
Brand name
METOCLOPRAMIDE
Generic name
METOCLOPRAMIDE
Manufacturer name
Teva Pharmaceuticals USA, Inc.
Product NDC
0093-2203, 0093-2204
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
METOCLOPRAMIDE HYDROCHLORIDE
RxCUI
311666, 311668
SPL ID
61b5d2d5-1e7b-44ff-a831-1a0de78edecd
SPL set ID
e15905e0-e0f6-4c8b-ac19-59724d6c4bf0
Package NDC
0093-2204-01, 0093-2204-05, 0093-2203-01, 0093-2203-05, 0093-2203-10
Is original packager
true
Upc
0300932203013, 0300932204010
UNII
W1792A2RVD
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.