April 2012 FDA Recall Mefloquine Hydrochloride by Teva Pharmaceuticals Usa, Inc.
D-1396-2012 - Tablet Thickness

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on April 2, 2012 for the product Mefloquine Hydrochloride. The FDA reported the reason for recall as tablet thickness. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1396-2012

Reason for Recall
Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.
Initiated
04-02-2012
Reported
07-04-2012
Quantity
4188 cartons (5 X 5 blisterpacks)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61664
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-22-2013
Product Description About Product Description
Full technical description of the product.
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

0555-0171-88 Mefloquine Hydrochloride
0555-0171-78 Mefloquine Hydrochloride