Drug recall: Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solut
FDA enforcement event 64611 is a drug recall by Shamrock Medical Solutions Group LLC of Lewis Center, OH, initiated 27 Sep 2011 and classified Class I, with 6 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 14% of the 22 drug enforcement events initiated in 2011 carry the same class.
Status: Terminated, terminated 31 Jul 2014. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Shamrock Medical Solutions Group LLC.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Shamrock Medical Solutions Group LLC, Lewis Center, OH.
Reason for recall
"Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules"
Distribution
"Product was shipped to the following states: CO, MA, OH, TX & WY."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1446-2014 | Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90 | 89/120 mg tablets | Class I | Terminated | 30 Jul 2014 |
| D-1447-2014 | Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36 | 55/1 mL/20mg/mL syringe | Class I | Terminated | 30 Jul 2014 |
| D-1448-2014 | metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01 | 88/5 mg tablets | Class I | Terminated | 30 Jul 2014 |
| D-1449-2014 | Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Northstar Rx, Memphis, TN NDC 16714-586-01 | 99/500 mg tablets | Class II | Terminated | 30 Jul 2014 |
| D-1450-2014 | 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 | 284/800 mg tablets | Class II | Terminated | 30 Jul 2014 |
| D-1451-2014 | Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60 | 99/240 mg softgel caps | Class II | Terminated | 30 Jul 2014 |
Context
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was shipped to the following states: CO, MA, OH, TX & WY."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Jul 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.