Lansoprazole Suspension Recalled Due to Temperature Storage Deviations
A prescription lansoprazole suspension has been recalled because batches were exposed to temperatures outside the manufacturer's labeled storage range. This manufacturing quality issue affects Batch 21025A nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for manufacturing quality deviations (temperature exposure) affecting a prescription pharmaceutical. Temperature exposure outside labeled storage conditions can compromise drug stability and efficacy; the hazard represents a risk-of-harm situation warranting High severity.
Plain-English summary
FIRST Lansoprazole PT, a prescription liquid suspension (3 mg/mL in 300 mL bottles), is being recalled nationwide due to manufacturing quality deviations. Products in Batch 21025A (NDC 65628-080-10) were exposed to temperatures outside the conditions labeled on the packaging. The product was distributed by CutisPharma, Inc., based in Woburn, Massachusetts.
Consumers who have this medication should contact their pharmacist or healthcare provider. Do not stop taking the medication without consulting a healthcare provider first. Ask your pharmacist whether your medication is part of the affected batch.
Temperature exposure outside labeled storage conditions may affect the stability and efficacy of medications. This manufacturing deviation triggered the FDA Class II recall.
The recalled product
- Product
- FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Oral Suspension
- Hazard
- storage-temperature-deviation
- manufacturing-defect
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)
- Batch 21025A
Distribution
Distributed nationwide across the United States.
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