Shamrock Medical Recalls Mislabelled Pramipexole Tablets Packaged as Nebivolol
Shamrock Medical Solutions is recalling Pramipexole Dihydrochloride tablets that were incorrectly labeled as Nebivolol. The error poses a risk of patients receiving the wrong medication.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric. The hazard involves a significant medication mix-up that could result in serious injury or death if the wrong drug is administered.
Plain-English summary
Shamrock Medical Solutions Group LLC is recalling Pramipexole Dihydrochloride Tablets, 0.5 mg, NDC 16714-586-01. The product was repackaged by Shamrock Medical Solutions in Lewis Center, Ohio, and manufactured by Northstar Rx in Memphis, Tennessee. The recall involves 99/500 mg tablets with a use-by date of 12/14/2012 and Lot# 002B90.
The recall was initiated due to a labeling error where the product was labeled to contain Nebivolol tablets but actually contained Pramipexole Dihydrochloride tablets. This mix-up could result in patients receiving an incorrect medication, which may lead to adverse health effects or lack of therapeutic benefit.
The affected product was shipped to Colorado, Massachusetts, Ohio, Texas, and Wyoming. Patients and healthcare providers should verify the contents of their medication against the NDC number and lot number provided. If the product matches the description, it should be returned to the pharmacy or contacting the recalling firm for instructions.
The recalled product
- Product
- 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
- 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 (3)
- Use by 12/14/2012
- Lot# 002B90
- NDC 16714-586-01
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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