Breckenridge Recalls Duloxetine Capsules Due to Foreign Omeprazole Capsule
Breckenridge Pharmaceutical is recalling 595 bottles of Duloxetine 60 mg capsules because one bottle contained a foreign omeprazole 10 mg capsule.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or packaging issues.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling 595 bottles of Duloxetine Delayed-release Capsules, USP, 60 mg, NDC 51991-748-10. The recall was initiated after a foreign capsule, identified as omeprazole 10 mg, was found in one of the bottles. The product was manufactured by Laboratorios Dr. Esteve, S.A., in Barcelona, Spain, and distributed by Breckenridge Pharmaceutical, Inc., in Boca Raton, Florida.
The affected product is identified by Lot # 142391 with an expiration date of 10/2016. The recall covers 1,000-count bottles distributed nationwide. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who have this specific lot of Duloxetine should stop using it and contact their healthcare provider or pharmacist for guidance. The presence of a foreign medication capsule in a prescription drug bottle represents a potential risk of unintended medication intake.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Category
- Drug — Prescription Medication
- Affected units
- 595
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 (2)
- Lot #: 142391
- Exp 10/2016
Distribution
Distributed nationwide across the United States.
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