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.
FDA recall notice · announced November 8, 2017 · Avkare
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot: 18103 Exp. 11/18
Quantity: 274 cartons
Status: Terminated
Products in this recall event:
- 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- (D-0055-2018)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.