FDA recall D-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.

Reason for recall

Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-10-06

Report date

2017-11-08

Termination date

2019-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0055-2018