PACK Pharmaceuticals, LLC

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1068-2014Class IIIOfloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are packaged in LoSeptember 9, 2013
D-1069-2014Class IIIOfloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The products are packaged in LSeptember 9, 2013
D-1070-2014Class IIITimolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). The products areSeptember 9, 2013
D-1072-2014Class IIITimolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). The products areSeptember 9, 2013
D-1073-2014Class IIITimolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10). The products areSeptember 9, 2013
D-1071-2014Class IIITimolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The products aSeptember 9, 2013
D-1422-2012Class IIICiprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: UniquMarch 9, 2012