CLASS I Drug recall · Reported 30 Jul 2014 · FDA Enforcement Report
metFORMIN ER Tablets, 500 mg, Rx, Packaged recalled
Shamrock Medical Solutions Group is recalling metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), distributed in Colorado, Massachusetts, Ohio, Texas, Wyoming. The recall was initiated on 27 Sep 2011 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1448-2014
- FDA event ID
- 64611
- Recalling firm
- Shamrock Medical Solutions Group, Lewis Center, OH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 27 Sep 2011
- FDA classified
- 23 Jul 2014
- Reported
- 30 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Drug class
- Diabetes Medication
Timeline
| 27 Sep 2011 | Recall initiated by company | |
| 23 Jul 2014 | Classified by FDA | +1030 days |
| 30 Jul 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix up; product labeled did not indicated Extended Release
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Product was shipped to the following states: CO, MA, OH, TX & WY.
Questions about this recall
Why was it recalled?
Labeling: Label Mix up; product labeled did not indicated Extended Release
Which lots are affected?
Lot #: 00267J Use By: 7/28/2012 NDC: 53746-178-01
Where was it sold?
Product was shipped to the following states: CO, MA, OH, TX & WY.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 64611| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Docusate Calcium Softgel Capsules, 240 mg recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states | |
| CLASS I | Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states | |
| CLASS I | Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states | |
| CLASS II | Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim | Shamrock Medical Solutions Group | Packaging Defects | 5 states | |
| CLASS II | Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
More recalls from Shamrock Medical Solutions Group
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS I | Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS I | Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS II | Docusate Calcium Softgel Capsules, 240 mg recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
Other Metformin recalls
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets 1000mg recalledMetformin Hydrochloride | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalledMetformin Er 500 Mg | Granules Pharmaceuticals | Other | OH |
| Drug | CLASS II | Metformin hydrochloride Extended-Release Tablets, 1000 mg recalled | Teva Pharmaceuticals USA | Nitrosamine Impurity | CA |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE recalledMetformin Hydrochloride | Viona Pharmaceuticals | Nitrosamine Impurity | NJ |