Reported Nov 18, 2015 · Terminated
Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve,…
Breckenridge Pharmaceutical, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Breckenridge Pharmaceutical, Inc · 15 Massirio Dr Ste 201 · Berlin, CT · 06037-2352
Is this the product you have?
- Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle
- Manufactured byLaboratorios Dr. Esteve, S.A., Barcelona, Spain
- Distributed byBreckenridge Pharmaceutical, Inc., Boca Raton, FL 33487
- NDC51991-748-10
- Lot codes and dates
Lot #: 142391Exp 10/2016
- Amount recalled
- 595 Bottles
Where it was sold
- Nationwide
Why it was recalled
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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