Pregabalin Capsule
FDA Recall NDC 47335-686
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 47335-686). A significant event, classified as Class II, was initiated on Oct 22, 2021 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient."
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
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Oct 22, 2021
Jan 12, 2022
696 Bottles
Recall Profile & Regulatory Data
Event ID
88927
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Apr 06, 2023
Product Description
Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.
Batch or Lot Expiration Information
Lot# Lot number: DNC0432A, expiration 01/2023
Affected Packages Involved in this Recall
47335-686-83Product
47335-686-88Product
47335-686-08Product
47335-686-18Product
47335-687-83Product
47335-687-88Product
47335-687-08Product
47335-687-18Product
47335-688-83Product
47335-688-88Product
47335-688-08Product
47335-688-18Product
47335-689-83Product
47335-689-88Product
47335-689-08Product
47335-689-18Product
47335-690-83Product
47335-690-88Product
47335-690-08Product
47335-690-18Product
47335-691-83Product
47335-691-88Product
47335-691-08Product
47335-691-18Product
47335-692-83Product
47335-692-88Product
47335-692-08Product
47335-692-18Product
47335-693-83Product
47335-693-88Product
47335-693-08Product
47335-693-18Product
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.
