Glenmark Generics Inc., USA

FDA Regulatory Profile

Glenmark Generics Inc., USA appears in FDA public data with 6 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1229-2014, Class II) was initiated on March 18, 2014.

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1229-2014Class IIRanitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals March 18, 2014
D-330-2013Class IIIGlenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, ManufactureApril 5, 2013
D-329-2013Class IIIGlenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- countApril 5, 2013
D-331-2013Class IIIGlenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by April 5, 2013
D-182-2013Class IIIMontelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-February 13, 2013
D-1701-2012Class IINAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark GenerJuly 6, 2012