Promethazine Hydrochloride Tablet
FDA Recall NDC 68382-040
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 Promethazine Hydrochloride (NDC 68382-040). A significant event, classified as Class II, was initiated on May 08, 2014 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles."
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
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
May 08, 2014
May 28, 2014
10,200 bottles
Recall Profile & Regulatory Data
Event ID
68285
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 26, 2016
Product Description
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01
Batch or Lot Expiration Information
Lot# : MN9081, Expiry: 09/2015
Affected Packages Involved in this Recall
68382-040-01Product
68382-040-05Product
68382-040-10Product
68382-041-01Product
68382-041-05Product
68382-041-10Product
68382-042-01Product
68382-042-05Product
68382-042-10Product
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.
