Aripiprazole Tablet
FDA Recall NDC 31722-830
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Aripiprazole (NDC 31722-830). A significant event, classified as Class II, was initiated on Jan 10, 2018 by Camber Pharmaceuticals, Inc.. 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 10, 2018
Feb 14, 2018
3000 bottles
Recall Profile & Regulatory Data
Event ID
78809
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hetero Labs, Ltd. - Unit III
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NJ Only
Termination Date
Sep 21, 2020
Product Description
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30
Batch or Lot Expiration Information
Lot# : ARI17089, ARI17090, Exp. 5/2019
Affected Packages Involved in this Recall
31722-820-30Product
31722-820-01Product
31722-820-31Product
31722-820-32Product
31722-820-05Product
31722-827-30Product
31722-827-01Product
31722-827-31Product
31722-827-32Product
31722-827-05Product
31722-819-30Product
31722-819-01Product
31722-819-31Product
31722-819-32Product
31722-819-05Product
31722-828-30Product
31722-828-01Product
31722-828-31Product
31722-828-32Product
31722-828-05Product
31722-829-30Product
31722-829-01Product
31722-829-31Product
31722-829-32Product
31722-829-05Product
31722-830-30Product
31722-830-01Product
31722-830-31Product
31722-830-32Product
31722-830-05Product
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.
