Mefloquine Hydrochloride Tablet
FDA Recall NDC 0555-0171
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 Mefloquine Hydrochloride (NDC 0555-0171). A significant event, classified as Class II, was initiated on Apr 02, 2012 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight."
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
Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.
Apr 02, 2012
Jul 04, 2012
4188 cartons (5 X 5 blisterpacks)
Recall Profile & Regulatory Data
Event ID
61664
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 22, 2013
Product Description
Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Carton: NDC 0555-0171-78
Batch or Lot Expiration Information
Lot# 34000741A; Expiration date: 7/2013
Affected Packages Involved in this Recall
0555-0171-88Product
0555-0171-78Product
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.
