Shamrock Recalls Metformin ER Tablets Labeled as Immediate Release
Shamrock Medical Solutions is recalling metformin ER tablets that were incorrectly labeled as immediate release. The mislabeling could lead to incorrect dosing.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class I recall. Per the rubric, FDA Class I recalls are assigned a minimum severity score of 4 (Severe) due to the reasonable probability of serious adverse health consequences or death.
Plain-English summary
Shamrock Medical Solutions Group LLC is recalling metformin ER tablets, 500 mg, NDC 53746-178-01. The product was repackaged by Shamrock Medical Solutions in Lewis Center, Ohio, and manufactured by Amneal/Interpharm in Hauppauge, NY.
The recall was initiated due to a labeling error where the extended-release (ER) tablets were packaged and labeled as immediate-release (IR) metformin. This discrepancy does not indicate the extended-release formulation on the label, which may result in patients or healthcare providers administering the medication incorrectly.
The affected product, Lot # 00267J with a use-by date of 7/28/2012, was shipped to Colorado, Massachusetts, Ohio, Texas, and Wyoming. Consumers and healthcare providers should check their inventory for this specific NDC and lot number. If found, the product should be returned to the pharmacy or supplier for a refund or replacement.
The recalled product
- Product
- 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
- Manufacturer
- Shamrock Medical Solutions Group LLC
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: 00267J Use By: 7/28/2012 NDC: 53746-178-01
Distribution
Part of a larger recall action
This product is one of 6 recalled by Shamrock Medical Solutions Group LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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