D-0181-2016 Class III Terminated
FDA drug recall D-0181-2016 was initiated by Breckenridge Pharmaceutical, Inc on Oct 21, 2015 and is designated Class III. Reason for recall: Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle The recall status is terminated (terminated Dec 24, 2015). Affected quantity: 595 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 18, 2015
- Initiation Date
- Oct 21, 2015
- Termination Date
- Dec 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 595 Bottles
Product Description
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
Reason for Recall
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Distribution Pattern
Nationwide
Code Information
Lot #: 142391, Exp 10/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0181-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026