Exact FDA event identifier

Event 64611

6 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 27, 2011
Product types: Drug
Classifications: Class I and Class II
Statuses: Terminated
Recalling firm wording: Shamrock Medical Solutions Group LLC

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 6

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

D-1446-2014

Recall number: D-1446-2014
Initiated: September 27, 2011
Classification: Class I
Status: Terminated
Recalling firm: Shamrock Medical Solutions Group LLC
Quantity: 89/120 mg tablets

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Mix Up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules

Code information

Use By: 5/31/2013, Lot: 0021OC, NDC 62037-0696-90

Distribution pattern

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

drug · product 2 of 6

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

D-1447-2014

Recall number: D-1447-2014
Initiated: September 27, 2011
Classification: Class I
Status: Terminated
Recalling firm: Shamrock Medical Solutions Group LLC
Quantity: 55/1 mL/20mg/mL syringe

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Mix up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL

Code information

Lot #: 002HZI Use By: 7/20/2013 NDC: 00527-1426-36

Distribution pattern

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

drug · product 3 of 6

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

D-1448-2014

Recall number: D-1448-2014
Initiated: September 27, 2011
Classification: Class I
Status: Terminated
Recalling firm: Shamrock Medical Solutions Group LLC
Quantity: 88/5 mg tablets

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Mix up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix up; product labeled did not indicated Extended Release

Code information

Lot #: 00267J Use By: 7/28/2012 NDC: 53746-178-01

Distribution pattern

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

drug · product 4 of 6

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

D-1449-2014

Recall number: D-1449-2014
Initiated: September 27, 2011
Classification: Class II
Status: Terminated
Recalling firm: Shamrock Medical Solutions Group LLC
Quantity: 99/500 mg tablets

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Mix up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets

Code information

Use by 12/14/2012, Lot# 002B90, NDC 16714-586-01

Distribution pattern

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

drug · product 5 of 6

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

D-1450-2014

Recall number: D-1450-2014
Initiated: September 27, 2011
Classification: Class II
Status: Terminated
Recalling firm: Shamrock Medical Solutions Group LLC
Quantity: 284/800 mg tablets

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Mix up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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

Code information

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

Distribution pattern

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

drug · product 6 of 6

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

D-1451-2014

Recall number: D-1451-2014
Initiated: September 27, 2011
Classification: Class II
Status: Terminated
Recalling firm: Shamrock Medical Solutions Group LLC
Quantity: 99/240 mg softgel caps

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Mix up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg

Code information

Lot #: 002H79, Use By: 06/19/2013, NDC: 00904-5779-60

Distribution pattern

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