Aripiprazole Tablet
FDA Recall NDC 60687-202
Latest: Class II · Status: Terminated · Initiated Jan 19, 2018 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Aripiprazole (NDC 60687-202). A significant event, classified as Class II, was initiated on Jan 19, 2018 by American Health Packaging. The reported reason for this action was: "CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Jan 19, 2018
Feb 21, 2018
270 cartons
Recall Profile & Regulatory Data
Event ID
79036
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AMERICAN HEALTH PACKAGING
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 14, 2019
Product Description
Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Batch or Lot Expiration Information
Lot# : 174096, Exp 05/31/19
Affected Packages Involved in this Recall
60687-157-11Aripiprazole
60687-157-21Aripiprazole
60687-157-94Aripiprazole
60687-168-11Aripiprazole
60687-168-01Aripiprazole
60687-168-65Aripiprazole
60687-179-11Aripiprazole
60687-179-01Aripiprazole
60687-179-65Aripiprazole
60687-191-11Aripiprazole
60687-191-21Aripiprazole
60687-191-94Aripiprazole
60687-202-11Aripiprazole
60687-202-21Aripiprazole
60687-202-94Aripiprazole
60687-213-11Aripiprazole
60687-213-21Aripiprazole
60687-213-94Aripiprazole
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
