Recalls / Class II
Class IID-1396-2012
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
- Brand name
- Mefloquine Hydrochloride
- Generic name
- Mefloquine Hydrochloride
- Active ingredient
- Mefloquine Hydrochloride
- Route
- Oral
- NDC
- 0555-0171
- FDA application
- ANDA076392
- Affected lot / code info
- Lot # 34000741A; Expiration date: 7/2013
Why it was recalled
Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 4188 cartons (5 X 5 blisterpacks)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-04-02
- FDA classified
- 2012-06-26
- Posted by FDA
- 2012-07-04
- Terminated
- 2013-03-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1396-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.