Shamrock Medical Solutions Group LLC

FDA Regulatory Profile

Summary

Total Recalls
6 (3 Class I)
510(k) Clearances
0
Inspections
4
Compliance Actions
3

Recent Recalls

NumberClassProductDate
D-1446-2014Class ITaztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: SSeptember 27, 2011
D-1449-2014Class IIPramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, September 27, 2011
D-1447-2014Class IOxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mSeptember 27, 2011
D-1451-2014Class IIDocusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mSeptember 27, 2011
D-1448-2014Class ImetFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), RepackagSeptember 27, 2011
D-1450-2014Class IISulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled September 27, 2011