Recalls / Class II
Class IID-0055-2018
Product
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.
- Affected lot / code info
- Lot: 18103 Exp. 11/18
Why it was recalled
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Recalling firm
- Firm
- AVKARE Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 274 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-10-06
- FDA classified
- 2017-10-27
- Posted by FDA
- 2017-11-08
- Terminated
- 2019-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0055-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.