Shamrock Medical Solutions Group metFORMIN ER Tablets Recall

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

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

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1448-2014
Classification: Class I
Status: Terminated
Recall initiated: Sep 27, 2011
FDA report date: Jul 30, 2014
Quantity: 88/5 mg tablets
Recall type: Voluntary: Firm initiated
Recalling firm: Shamrock Medical Solutions Group LLC

Original FDA data

Every field from FDA enforcement report D-1448-2014, exactly as published.

Show all FDA fields

City: Lewis Center
State: OH
Status: Terminated
Country: United States
Event ID: 64611
Address: 741 Radio Dr
Code information: Lot #: 00267J Use By: 7/28/2012 NDC: 53746-178-01
Postal code: 43035-7134
Report date: Jul 30, 2014
Product type: Drugs
Recall number: D-1448-2014
Classification: Class I
Recalling firm: Shamrock Medical Solutions Group LLC
Product quantity: 88/5 mg tablets
Termination date: Jul 31, 2014
Reason for recall: Labeling: Label Mix up; product labeled did not indicated Extended Release
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Product was shipped to the following states: CO, MA, OH, TX & WY.
Recall initiation date: Sep 27, 2011
Initial firm notification: Telephone
Center classification date: Jul 23, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1448-2014, published Jul 30, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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