Amitriptyline Hydrochloride Tablet, Film Coated
FDA Recall NDC 0781-1487
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 Amitriptyline Hydrochloride (NDC 0781-1487). A significant event, classified as Class III, was initiated on Jun 16, 2017 by Sandoz Inc. The reported reason for this action was: "Cross Contamination With Other Product: Imipramine"
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 III Terminated
Cross Contamination With Other Product: Imipramine
Jun 16, 2017
Jul 12, 2017
38,234 bottles
Recall Profile & Regulatory Data
Event ID
77567
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sandoz Incorporated
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States
Termination Date
Jan 14, 2019
Product Description
Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540
Batch or Lot Expiration Information
Lot# : a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019.
Affected Packages Involved in this Recall
0781-1486-10Product
0781-1486-01Product
0781-1486-31Product
0781-1487-10Product
0781-1487-01Product
0781-1487-31Product
0781-1488-10Product
0781-1488-01Product
0781-1488-31Product
0781-1489-31Product
0781-1489-01Product
0781-1489-10Product
0781-1490-10Product
0781-1490-01Product
0781-1490-31Product
0781-1491-10Product
0781-1491-01Product
0781-1491-31Product
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.
