Shamrock Medical Recalls Mislabelled Diltiazem Capsules Packaged as Thiamine
Shamrock Medical Solutions is recalling Diltiazem HCl capsules that were incorrectly labeled as Thiamine. The error could lead to patients receiving the wrong medication.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death. Mislabeling a prescription drug as a vitamin is a critical safety hazard.
Plain-English summary
Shamrock Medical Solutions Group LLC is recalling Taztia XT (Diltiazem HCl) Capsules, 120 mg, which were packaged and labeled as Thiamine. The product was manufactured by Watson Laboratories and re-packaged by Shamrock Medical Solutions in Lewis Center, Ohio.
The recall is due to a labeling mix-up where packages containing Diltiazem Capsules were incorrectly labeled as Thiamine. This error poses a risk of patients or healthcare providers administering the wrong medication. The affected product has the NDC 62037-0696-90, Lot 0021OC, and a Use By date of 5/31/2013.
The product 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 supplier or disposed of according to local regulations. Patients should consult their healthcare provider if they have received or taken this mislabeled product.
The recalled product
- Product
- 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
- 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: 5/31/2013
- Lot: 0021OC
- NDC 62037-0696-90
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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