Recalls / Class III
Class IIID-0181-2016
Product
Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10
- Brand name
- Duloxetine
- Generic name
- Duloxetine Hydrochloride
- Active ingredient
- Duloxetine Hydrochloride
- Route
- Oral
- NDCs
- 51991-746, 51991-747, 51991-748, 51991-750
- FDA application
- ANDA203088
- Affected lot / code info
- Lot #: 142391, Exp 10/2016
Why it was recalled
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 15 Massirio Dr Ste 201, N/A, Berlin, Connecticut 06037-2352
Distribution
- Quantity
- 595 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-10-21
- FDA classified
- 2015-11-10
- Posted by FDA
- 2015-11-18
- Terminated
- 2015-12-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0181-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.