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Recall Observatory FDA recall evidence

Drug 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

D-1396-2012

April 02, 2012

Class II

Product summary

Firm
Teva Pharmaceuticals USA, Inc.
Event
Event 61664
Status
Terminated
Classification
Class II
Quantity
4188 cartons (5 X 5 blisterpacks)
Official record key
drug-enforcement:D-1396-2012

Official wording

Reason: Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.

Code information: Lot # 34000741A; Expiration date: 7/2013

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.