FDAFDA · Food and drugs·Recall number D-0055-2018
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
Published November 8, 2017 · Recall initiated: October 6, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AVKARE Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot: 18103 Exp. 11/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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