FDA-Drug2017-11-08Class II
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.
AVKARE Inc.
Hazard
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Sold states
Nationwide in the USA
Affected count
274 cartons
Manufactured in
615 N 1st St, N/A, Pulaski, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0055-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief