Pregabalin Capsule
FDA Recall NDC 43598-293
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 Pregabalin (NDC 43598-293). A significant event, classified as Class II, was initiated on Mar 15, 2021 by Dr.reddys Laboratories Inc. The reported reason for this action was: "CGMP Deviations: Intermittent exposure to temperature excursion during storage."
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: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
6 CONTAINERS
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES
Batch or Lot Expiration Information
Lot# T2000309
Affected Packages Involved in this Recall
43598-291-90Product
43598-291-05Product
43598-291-79Product
43598-291-66Product
43598-291-78Product
43598-292-90Product
43598-292-05Product
43598-292-79Product
43598-292-66Product
43598-292-78Product
43598-293-90Product
43598-293-05Product
43598-293-79Product
43598-293-66Product
43598-293-78Product
43598-294-90Product
43598-294-05Product
43598-294-79Product
43598-294-66Product
43598-294-78Product
43598-295-90Product
43598-295-05Product
43598-295-79Product
43598-295-66Product
43598-295-78Product
43598-296-90Product
43598-296-05Product
43598-296-79Product
43598-296-66Product
43598-296-78Product
43598-297-90Product
43598-297-05Product
43598-297-79Product
43598-297-66Product
43598-297-78Product
43598-298-90Product
43598-298-05Product
43598-298-79Product
43598-298-66Product
43598-298-78Product
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.
