Lansoprazole Delayed-Release Capsules Recalled for Out-of-Specification Dissolution
Preferred Pharmaceuticals is recalling certain lots of Lansoprazole Delayed-Release Capsules 15mg due to dissolution testing results that do not meet specifications. Approximately 791 bottles were distributed 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 with no reported illnesses or injuries. The hazard is theoretical, discovered through stability testing rather than patient reports, which limits the score to 3 per the rubric criteria.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling specific lots of Lansoprazole Delayed-Release Capsules, 15mg (generic for Prevacid), due to results from long-term stability testing that showed the medication does not meet dissolution specifications. Dissolution is the rate at which a capsule breaks down and releases its medication in the body.
The recalled product is the 90-count bottle with National Drug Code (NDC) 68788-6390-09, manufactured by Dr Reddy's Laboratories Limited. The affected lot codes are H0221R, D3021T, D2221J, and D1321X, with an expiration date of December 31, 2023. Approximately 791 bottles were distributed nationwide in the United States and Canada.
Patients taking this medication should contact their healthcare provider or pharmacist for guidance. Do not stop taking the medication without speaking to a healthcare professional first. Any unused product should be returned to the place of purchase or disposed of according to pharmacist instructions.
The recalled product
- Product
- Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delayed-Release Capsules, 15mg, Generic for Prevacid, 90-Count Bottle, Manufacturer: Dr Reddy's Laboratories Limited, NDC 68788-6390-09
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Oral Medication
- Hazard
- dissolution-defect
- product-quality
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 (5)
- Lots: H0221R
- D3021T
- D2221J
- D1321X
- Exp.12/31/2023.
Distribution
Distributed nationwide across the United States.
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