Home / Recalls / Shamrock Medical Solutions Group LLC / D-1450-2014

D-1450-2014 Class II Terminated

Recalled by Shamrock Medical Solutions Group LLC — Lewis Center, OH

Recall Details

Product Type
Drugs
Report Date
July 30, 2014
Initiation Date
September 27, 2011
Termination Date
July 31, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
284/800 mg tablets

Product Description

Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01

Reason for Recall

Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg

Distribution Pattern

Product was shipped to the following states: CO, MA, OH, TX & WY.

Code Information

Lot 00288N, Use By: 9/15/2012, NDC 53746-272-01

Other recalls by Shamrock Medical Solutions Group LLC

  • D-1446-2014 Class I — Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine (September 27, 2011)
  • D-1449-2014 Class II — Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain (September 27, 2011)
  • D-1447-2014 Class I — Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morp (September 27, 2011)
  • D-1451-2014 Class II — Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain (September 27, 2011)
  • D-1448-2014 Class I — metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Re (September 27, 2011)